Quality, compliance and production
GERATI laryngoscopes are made in Sialkot, Pakistan, under an ISO 13485:2016 quality management system, and CE marked as Class I medical devices under the EU MDR. This page lists the certificates and declarations behind each product, and shows how a blade is made and checked.
- ISO 13485:2016
- EU MDR Class I, CE marked
- EU authorised representative
- Made in Sialkot, Pakistan
Certificates and declarations
The documents below are the basis for the "ISO 13485" and "CE marked" statements on our laryngoscope pages. Copies are sent on request.
ISO 13485:2016 certificate
- Certificate
- 06202/INT85A
- Issued by
- RoyalCert International Registrars
- Recertified
- 21 January 2024
- Valid until
- 20 April 2028
- Scope
- Manufacturing and export of medical, metallic, surgical, laparoscopic and dental instruments and parts
The certificate can be verified with RoyalCert at royalcert.com.
EU Declaration of Conformity
- Reference
- IMI-QM-DOC002, Rev. 04
- Issued
- 9 July 2026
- Regulation
- (EU) 2017/745 (EU MDR)
- Class
- Class I, reusable
- Route
- Article 52(7), self-declaration; no notified body
- Covers
- Reusable laryngoscope blades, battery handles and sets
EUDAMED and EU representative
- Manufacturer
- GERATI Healthcare (Pvt) Ltd., Sialkot
- SRN
- PK-MF-000058307
- EU authorised representative
- Yellow's Medical Instruments GmbH, Max-Planck Str. 3, 12489 Berlin, Germany
- AR SRN
- DE-AR-000007390
Standards applied
Listed in our EU Declaration of Conformity:
| Standard | Subject |
|---|---|
| ISO 13485:2016 | Quality management system |
| EN ISO 14971:2019 | Risk management |
| EN ISO 10993-1:2018 | Biological evaluation |
| EN ISO 7153-1:2016 | Stainless steel for instruments |
| ASTM A967 / EN ISO 13402 | Passivation; resistance to autoclaving and corrosion |
| EN ISO 17664-1:2021 | Reprocessing information |
| EN ISO 17665-1:2006 | Moist heat sterilization |
| EN ISO 20417:2021 | Information supplied by the manufacturer |
| EN ISO 15223-1:2021 | Labelling symbols |
Blades and handles are designed to the hook-on fitting dimensions in ISO 7376, with fiber optic models designed for green-system compatibility.
Documents for registration
Importers and tender suppliers can request:
- ISO 13485 certificate
- EU Declaration of Conformity and CE documentation
- Technical file summary and product specifications
- Test reports
- Free sale certificate and certificate of origin
- IFU and labelling files
Registration requirements differ by country and change over time, so confirm them with your local authority.
Request documentsHow a GERATI blade is made
Every stage, from sheet metal to final inspection, takes place in our facility in Sialkot, Pakistan.
Blade blanks
Blanks are cut from AISI 304 stainless steel sheet and formed to the blade profile. Material is checked at goods-in.
Heel blocks
The heel blocks that carry the hook-on fitting are machined separately, then checked against the ISO 7376 fitting dimensions.
Joining
The blade, heel and light guide tube are joined into one part. On fixed tube blades the fiber tube is laser welded.
Finishing
Blades are ground, polished and passivated, then given a satin anti-glare or mirror finish. Laser marking follows.
Packing
Inspected handles and blades are packed individually to protect the finish, then boxed or cased with their batch records.
Made under one roof
Because blades, heels and handles are all made in-house, finishes, markings and design details can be changed for OEM orders without passing through a chain of subcontractors.
A quality inspector checks a fiber optic blade on a battery handle.
Quality checks
- Incoming inspection of stainless steel, brass and components
- Dimensional checks of blades and handles
- Fit and lock checks of blades on handles to ISO 7376 dimensions
- Light output and electrical function testing
- Finish and laser marking inspection
- Final inspection before packing, with batch records kept for traceability
Materials, reprocessing and warranty
Materials
Blades in AISI 304 stainless steel. Handles with a stainless steel connector and chrome-plated brass body.
Reprocessing
Blades: steam autoclave up to 134 °C or high-level disinfection. Remove lamps and batteries first, and follow the instructions for use.
Warranty
5 years on blades and handles against material and manufacturing defects. Lamps and batteries are excluded.
Selling under your own brand? When a product is sold under your brand, your regulator may treat your company as the legal manufacturer, especially under the EU MDR. We explain what applies in your market and supply the documents we hold. Read about OEM responsibilities.
Frequently asked questions
Is GERATI certified to ISO 13485?
Yes. GERATI Healthcare's quality management system is certified to ISO 13485:2016 by RoyalCert International Registrars, certificate 06202/INT85A, valid until 20 April 2028.
Are GERATI laryngoscopes CE marked?
Yes. GERATI reusable laryngoscope blades, battery handles and sets are CE marked as Class I medical devices under the EU Medical Device Regulation (EU) 2017/745, on the basis of GERATI's EU Declaration of Conformity.
Is a notified body involved?
No. Non-sterile, non-measuring Class I devices are self-declared by the manufacturer under Article 52(7) of the EU MDR. No notified body certificate is required.
Who is GERATI's EU authorised representative?
Yellow's Medical Instruments GmbH, Berlin, Germany (SRN DE-AR-000007390). GERATI's own single registration number is PK-MF-000058307.
What documents can you provide for product registration?
ISO 13485 certificate, EU Declaration of Conformity and CE documentation, technical file summary, test reports, free sale certificate, certificate of origin, and IFU and label files. Requirements differ by country, so confirm with your local authority.
Where are GERATI laryngoscopes made?
In GERATI's facility in Sialkot, Pakistan, from material inspection to final inspection and packing.
Request documents or a factory audit
Tell us your market and the documents your regulator or tender requires. We reply with what we can supply and when.
Email sales@gerati.com WhatsApp +92 300 8610614- ISO 13485:2016, certificate 06202/INT85A
- EU MDR Class I, DoC IMI-QM-DOC002
- SRN PK-MF-000058307
- EU authorised representative in Berlin
- Made in Sialkot, Pakistan