01 - Which Model Fits Your Business
Three Ways to Source from GERATI
Most buyers fall into one of three sourcing models. Knowing which applies to you determines what documentation you need, what minimum order quantities apply, and how the regulatory responsibilities are structured.
Private LabelMost Common
GERATI's product, your brand. The instrument design and specification is GERATI's standard range. You provide your brand name, logo, and packaging brief. We manufacture, brand, and supply under your label.
Your brand name on the instrument and packaging
GERATI's standard specification - no design cost
Fastest to market - no tooling lead time
Lower MOQ - suitable for market entry
EU MDR legal manufacturer obligations apply - see Section 4
OEM Custom Spec
Your specification, your brand. You define the product design - specific dimensions, materials, harpoon type, handle geometry. GERATI manufactures to your specification under your brand name.
Custom product specification and design
Design review and engineering support included
Tooling cost and lead time required upfront
Higher MOQ - commercial volume orders
Full technical file transfer available
Wholesale Stock
GERATI's product, GERATI's brand. You distribute under our label. No branding overhead. Fastest delivery from stock. Best for distributors who want a quality-certified product to resell without brand investment.
GERATI branded product supplied as-is
No branding cost or lead time
Available from stock for fast delivery
No EU MDR legal manufacturer obligations on distributor
Tiered pricing by volume
02 - What You Can Customise
Branding and Customisation Options
GERATI's manufacturing setup in Sialkot supports the following customisation options for private label and OEM buyers. Each option has different lead time and MOQ implications.
Laser Engraving on Instrument Body
Your brand name, logo, or product reference laser marked directly onto the stainless steel barrel. Permanent, autoclave-resistant. No degradation through repeated sterilisation cycles. The preferred marking method for medical instruments intended for hospital use.
Custom Packaging and Labelling
Individual blister packs or folding cartons with your brand design. Multilingual label text in English, French, German, Spanish, Arabic or as required. EU-compliant labelling with all mandatory MDR information including UDI, manufacturer address, CE mark, and IFU reference.
Custom Colour and Surface Finish
Standard finish is polished stainless steel. Knurled grip finish available on request. Some buyers specify a specific surface texture or handle colour for product differentiation within their range. Discuss during the specification review stage.
Specification Modifications
Thread standard (EU metric or AM imperial), barrel length, thumb ring diameter, finger rest span, harpoon type, and petite vs standard size can all be specified per order. Custom specification changes may require engineering review and affect MOQ and lead time.
Cook-Waite pattern available: The Cook-Waite (C-W) pattern is the most widely specified design in North American and many international export markets. GERATI manufactures to C-W pattern specifications as standard alongside our own design. If your distributor contracts specify C-W pattern, confirm this at enquiry stage.
03 - The OEM Process
How the OEM and Private Label Process Works
From first enquiry to delivery, here is the standard process for a private label or OEM order with GERATI. Timeline varies by customisation scope.
1
Submit your enquiry with product specification
Email sales@gerati.com with your company name, target market, product specification (aspirating type, thread standard, material, size), branding requirements, and estimated annual volume. The more detail you provide, the faster and more useful the response. We respond within 2 working days.
2
Receive pricing, MOQ, and sample proposal
We provide a pricing schedule by volume tier, the minimum order quantity for your specification, sample availability, and lead time for the first production run. For private label orders requiring custom packaging, a packaging brief and print-ready artwork format is also provided at this stage.
3
Request and evaluate samples
Pre-production samples are supplied for your evaluation before the full production run is confirmed. For private label orders, a branded sample with your label is produced first. You approve the sample before production begins. This stage is critical - do not skip it, regardless of time pressure.
4
Confirm regulatory structure for your market
For EU market supply under your brand name, confirm whether GERATI or your company will be the named legal manufacturer on the CE Declaration of Conformity. This determines the documentation package and your regulatory obligations. See Section 4 for the full explanation. This step is mandatory before production is confirmed for EU-bound orders.
5
Place confirmed order with purchase order
A formal purchase order confirms the product specification, quantity, branding, delivery address, and required documentation. Production begins on receipt of the agreed deposit. Lead time for standard private label orders from confirmed PO is typically 4 to 6 weeks. Custom OEM specification orders with tooling requirements: 8 to 12 weeks for first production run.
6
Quality inspection and pre-shipment documentation
Every production batch is inspected under GERATI's ISO 13485 quality management system before shipment. You receive the inspection report, CE Declaration of Conformity, and EN ISO 17664-1 reprocessing IFU with the shipment. For custom OEM orders requiring separate technical documentation, this is prepared and transferred at this stage.
7
Shipment and ongoing supply partnership
Shipment is by DHL or FedEx international express, or by sea freight for large volume orders. Delivery timelines depend on destination - Europe typically 4 to 6 days, Middle East 3 to 5 days, further markets 5 to 10 days. We support ongoing repeat orders with stable pricing and priority production scheduling for established OEM partners.
04 - Critical Regulatory Information
EU MDR Private Label Obligations: What Changed and What It Means for You
This is the section most OEM competitor pages do not cover. The rules for private label medical device manufacturers changed fundamentally under EU MDR 2017/745 compared to the old Medical Device Directive (MDD 93/42/EEC). If you are a distributor planning to sell GERATI-manufactured syringes under your own brand name in the EU, you need to understand this before placing your first order.
What was allowed under the old MDD
Under MDD 93/42/EEC, a distributor could place their brand on a CE-marked OEM product, apply for CE conformity using the OEM's certificate, and sell it in the EU - without holding the manufacturer's complete technical file. The original equipment manufacturer held the technical file. The private label company just needed a simplified version.
What changed under EU MDR 2017/745
Under EU MDR 2017/745, which came into full application in May 2021, this arrangement is no longer possible in its original form. Article 10(4) of the MDR requires that the company named as manufacturer on the product label must hold a complete version of the Technical Documentation as per Annexes II and III of the MDR.
The key change: If your company name appears as the manufacturer on the CE label of a dental syringe sold in the EU, you are the legal manufacturer under EU MDR - regardless of who physically made the instrument. You must hold the full technical file, issue the Declaration of Conformity in your name, and maintain post-market surveillance obligations. This applies even if the physical manufacture is entirely done by GERATI.
The two compliant options for EU OEM supply
Option A - GERATI named as manufacturer: GERATI is identified as the manufacturer on the label and in the instructions. Your company distributes the product. You are a distributor under EU MDR, not a manufacturer. Your regulatory obligations are significantly lighter - you verify that the product is CE marked, that the DoC exists, and that labelling requirements are met. This is the simplest structure and the most common for new OEM relationships.
Option B - Your company named as manufacturer: Your company name appears as the legal manufacturer on the label. GERATI grants you full access to the complete technical documentation. You issue the Declaration of Conformity in your company's name. You take on the full manufacturer regulatory obligations including post-market surveillance and incident reporting. This option gives you complete brand control but requires internal regulatory capability or a regulatory consultant.
GERATI's position: We support both structures. For new OEM partnerships entering the EU market, we typically recommend starting with Option A - GERATI named as manufacturer - to avoid the regulatory burden while you establish your market. As your volume and brand investment grows, we can support a structured transition to Option B with full technical file transfer. Discuss your regulatory strategy with us at the enquiry stage.
Source: The regulatory change is documented in EU MDR 2017/745 Article 10(4) and Article 16, and confirmed by the Frontiers in Dental Medicine MDR review (2023) and the mdi Europa OEM/Private Labelling analysis. If you are working with a regulatory consultant, share these references with them when structuring your arrangement.
05 - What You Can Order
Product Specifications Available for OEM and Private Label
| Specification | Standard Options | Custom OEM |
|---|---|---|
| Aspiration type | Aspirating (harpoon), Non-aspirating, Self-aspirating | All types |
| Thread standard | EU metric 1.8ml, AM imperial 2.2ml | Both available |
| Body material | Grade 410 solid stainless steel, Brass with chrome plating | Specify grade on order |
| Size | Standard, Petite | Custom dimensions available |
| Finger rest | 2-finger rest, 3-ring | Custom geometry available |
| Pattern design | GERATI standard, Cook-Waite pattern | Custom pattern with tooling |
| Surface finish | Polished, Knurled grip | Discuss at enquiry |
| Branding | Laser engraved brand name/logo on barrel | Full custom branding |
| Packaging | Standard GERATI packaging, Custom branded box/blister | Full custom packaging |
| MOQ - private label | Flexible - discuss at enquiry stage | Higher MOQ for tooling orders |
| CE documentation | DoC in GERATI name (Option A) | DoC in buyer name with full tech file (Option B) |
06 - Documentation for OEM Buyers
What Documentation OEM and Private Label Buyers Receive
The documentation package differs between Option A (GERATI as named manufacturer) and Option B (buyer as named manufacturer). Both are compliant with EU MDR 2017/745.
| Document | Option A (GERATI named) | Option B (Buyer named) |
|---|---|---|
| CE Declaration of Conformity | GERATI name - supplied with order | Buyer name - buyer issues using GERATI tech file |
| ISO 13485:2016 Certificate | GERATI certificate - on request | GERATI certificate plus buyer's own QMS |
| EN ISO 17664-1 Reprocessing IFU | GERATI branded - with every order | Buyer branded - developed from GERATI data |
| Complete Technical File | Held by GERATI - not transferred | Transferred to buyer - required for Option B |
| Material Certificates | On request for commercial orders | Included in technical file transfer |
| Post-Market Surveillance | GERATI responsible - buyer reports incidents to GERATI | Buyer responsible - full PMS obligation transfers |
Start Your OEM or Private Label Enquiry
Email with your company name, target market, product specification, and annual volume estimate. We respond within 2 working days.
07 - FAQs
Frequently Asked Questions
What is the minimum order quantity for private label dental syringes from GERATI?
Minimum order quantities are flexible and depend on the product specification, customisation level, and your target market. For private label orders using GERATI's standard specification with laser-engraved branding only, MOQs are lower than for orders requiring custom packaging design and print setup. For custom OEM orders that require tooling modifications to the instrument design, MOQs are higher to recover tooling costs. We do not publish fixed MOQs because they vary by specification. Submit your enquiry with your product requirements and estimated annual volume and we will provide the applicable MOQ along with tiered pricing. Trial orders below standard MOQ can be discussed for first-time buyers evaluating product quality before committing to a full production run.
Can I sell GERATI-manufactured dental syringes under my own brand name in the EU?
Yes, but the structure of the arrangement depends on your regulatory position. Under EU MDR 2017/745, if your company name appears as the manufacturer on the CE label, you become the legal manufacturer and must hold the complete technical documentation, issue the CE Declaration of Conformity in your name, and maintain post-market surveillance obligations. If GERATI's name appears as the manufacturer on the label and your company distributes the product, you are a distributor under EU MDR with significantly lighter obligations. Most new OEM partners start with GERATI named as manufacturer (Option A) to avoid the regulatory overhead of Option B. We support both structures. The choice depends on your regulatory capability, brand strategy, and target market. See Section 4 for the full explanation.
What changed for private label dental device manufacturers under EU MDR compared to the old MDD?
Under the old Medical Device Directive (MDD 93/42/EEC), a private label manufacturer could place their brand on a CE-marked OEM product and apply for CE conformity using the OEM's certificate, without holding the complete technical file. Under EU MDR 2017/745, which came into full application in May 2021, this is no longer possible. Article 10(4) of the MDR requires that the company named as manufacturer on the label must hold a complete version of the Technical Documentation as per Annexes II and III. In practice this means: if you want your brand name on a dental syringe CE label for the EU market, you must either hold the complete technical file yourself or have GERATI named as manufacturer on the label with you as distributor. The traditional private label model where a distributor held only a simplified technical file is not compliant with MDR.
What branding options are available for private label dental syringes?
GERATI offers laser engraving of your brand name and logo directly onto the stainless steel barrel of the syringe. Laser marking is permanent and autoclave-resistant - it does not degrade through repeated sterilisation cycles and does not affect the surface integrity of the instrument. Custom packaging is also available: individual blister packs or folding cartons with your brand design, in single or multiple languages. Packaging label content must meet EU MDR labelling requirements if the product is sold in the EU - including UDI, manufacturer name and address, CE mark, lot number, and IFU reference. We can advise on compliant label design. For custom instrument design beyond branding - different handle geometry, specific dimensions, custom harpoon type - this is possible as a full OEM order with tooling cost and longer lead time.
What is the lead time for private label dental syringe orders?
Lead times depend on the customisation scope. For private label orders using GERATI's standard instrument with laser engraving only and GERATI's standard packaging with your label applied: typically 3 to 4 weeks from confirmed purchase order and deposit. For private label orders requiring custom packaging design, print, and branded blister packs: typically 5 to 7 weeks from approved artwork, as the packaging production adds lead time. For full OEM orders requiring instrument tooling modifications: 8 to 12 weeks for the first production run from confirmed specification. Repeat orders on an established specification are significantly faster. Lead times are confirmed at the quotation stage and included in the purchase order confirmation.
Does GERATI supply a CE Declaration of Conformity for private label orders?
Yes, for Option A arrangements where GERATI is named as the legal manufacturer on the label, GERATI supplies the CE Declaration of Conformity with every commercial order. The DoC references EU MDR 2017/745 and the harmonised standards EN ISO 9997:2020 and EN ISO 17664-1. For Option B arrangements where your company is named as the legal manufacturer, your company issues the DoC in your own name - GERATI provides the technical documentation to enable this. The DoC format, mandatory content, and signatory requirements are defined in EU MDR 2017/745 Annex IV. If you are setting up an Option B arrangement, your regulatory consultant should review the DoC template before the first order is placed.
Can GERATI supply dental syringes to the Cook-Waite pattern specification?
Yes. The Cook-Waite (C-W) pattern is the most widely specified dental syringe design in North American and many international export markets. GERATI manufactures to C-W pattern specifications as a standard OEM option alongside our own proprietary design. The C-W pattern defines specific barrel geometry, flange configuration, and handle dimensions that are recognised across the dental distribution industry. If your distributor contracts or hospital procurement tender specifications reference Cook-Waite pattern, confirm this in your enquiry and we will confirm the specification match and provide samples for your approval before production.
What information should I include in my first OEM enquiry to GERATI?
The more specific your first enquiry, the faster and more useful our response. Include: (1) Your company name and the country you are based in. (2) Target market - the country or region where the product will be sold. (3) Supply model - private label under your brand, or wholesale under GERATI brand. (4) Product specification - aspirating or non-aspirating, EU thread (1.8ml) or AM thread (2.2ml), stainless steel or brass/chrome, standard or petite size. (5) Branding requirements - laser engraving only, custom packaging, both, or none. (6) Estimated annual volume or initial order quantity. (7) Timeline - when you need the first delivery. (8) Documentation requirements - any specific certifications required by your target market beyond CE and ISO 13485. Send to sales@gerati.com or use the contact form. We respond within 2 working days.
Start Your OEM Enquiry
Email with your company name, target market, product specification, and volume estimate. We respond within 2 working days with pricing, MOQ, and sample availability.
- Private label and custom branding available
- ISO 13485:2016 - CE MDR 2017/745
- Cook-Waite pattern available
- EU and AM thread - both configurations
- Full technical file transfer for Option B buyers