Dental Instruments Suppliers in Kenya — ISO 13485 Certified
As trusted dental instruments suppliers in Kenya, GERATI Healthcare delivers CE-marked dental forceps, scalers & extraction sets wholesale to Kenyan hospitals, clinics & distributors — direct from our Sialkot, Pakistan manufacturing facility. ISO 13485:2016 certified · CE MDR 2017/745 marked.
MOQ: 50 units ·
Lead Time: 3–5 weeks ·
CIF Mombasa available ·
ISO 13485 & CE MDR manufacturer documentation included
Dental instruments suppliers in Kenya face growing demand as the country’s Universal Health Coverage programme expands access to over 54 million patients across 2,600+ registered dental clinics and public hospitals. GERATI Healthcare — ISO 13485:2016 certified, CE MDR 2017/745 marked, and manufactured from premium surgical-grade stainless steel in Sialkot, Pakistan — supplies wholesale dental forceps, scalers, curettes, mirrors, and extraction sets direct to Nairobi distributors, Mombasa-based importers, and East African hospital procurement teams. We provide our complete ISO 13485 certificate, CE Declaration of Conformity, Certificate of Origin, Technical File, and IFU with every order to support your PPB Kenya Class B product registration application. Request your Kenya RFQ today →
Dental Instruments Available for Kenya
ISO 13485-certified · Wholesale supply · Factory-direct from Sialkot Pakistan
Extraction Forceps
Upper/lower molar & premolar. Surgical-grade SS. ISO 7376 compatible. Wholesale sets.
Scalers & Curettes
Gracey, Universal, Sickle. Autoclave 134°C safe. Full wholesale sets available.
Mirrors & Probes
Mouth mirrors No. 4 & 5. Double-ended probes. Complete examination sets.
Dental Elevators
Coupland, Warwick James, Cryer sets. Surgical SS. MOQ 50 units per set.
Technical Specifications — Kenya Supply
| Instrument | Material | Sterilization | Certifications | MOQ Kenya |
|---|---|---|---|---|
| Extraction Forceps — Upper Molar | Surgical SS | Autoclave 134°C | ISO 13485CE MDR | 50 units |
| Gracey Curette Set | Surgical SS | Autoclave 134°C | ISO 13485 | 50 units |
| Mouth Mirror No. 4 & 5 | Surgical SS + Glass | Autoclave 134°C | ISO 13485 | 100 units |
| Dental Probe — Double Ended | Surgical SS | Autoclave 134°C | ISO 13485CE MDR | 100 units |
| Dental Elevators — Coupland Set | Surgical SS | Autoclave 134°C | ISO 13485 | 50 units |
Sourcing Dental Instruments in Kenya
Kenya is East Africa’s largest medical device import market, with over 54 million people served by 2,600+ registered dental clinics and a rapidly expanding private healthcare sector under the Universal Health Coverage programme. Major procurement channels include KEMSA, Aga Khan Health Services, Nairobi Hospital, and AAR Healthcare. The Pharmacy and Poisons Board (PPB) enforces Class B medical device registration requirements for all imported dental instruments. GERATI provides a comprehensive manufacturer documentation package — ISO 13485 certificate, CE Declaration of Conformity, Certificate of Origin, Technical File, and IFU — to support your PPB Kenya Class B product registration application.
Manufacturer Documentation Package Included: GERATI provides ISO 13485:2016 QMS certificate, CE Declaration of Conformity (MDR 2017/745), Certificate of Origin (COO) from Sialkot Chamber of Commerce, Product Technical File, Instructions for Use (IFU), and Packing List with HS Code 9018.49 — everything your importer needs to support a PPB Kenya Class B registration application. Product registration with PPB Kenya is completed by your local importer using these manufacturer documents.
Why Kenya Distributors Choose GERATI
Factory-Direct from Sialkot
No intermediaries — Sialkot Pakistan to Nairobi direct. MOQ 50 units per product family. Competitive CIF Mombasa pricing.
Full Manufacturer Documentation
ISO 13485 certificate · CE DoC · COO · Technical File · IFU — all provided to support your PPB Kenya registration. No extra charge.
OEM / Private Label
Custom branding & packaging for Kenyan distributors. ISO 13485 OEM documentation available. Flexible configurations.
Shipping Dental Instruments to Kenya
Sialkot / Karachi → Mombasa Port · Air freight via JKIA Nairobi
GERATI Supplies Dental Instruments Across Africa
Single ISO 13485-certified supplier · Multi-market manufacturer documentation
As dedicated dental instruments suppliers in Kenya and across Africa, GERATI Healthcare serves the full continent from a single ISO 13485-certified manufacturing facility in Sialkot, Pakistan.
Frequently Asked Questions — Dental Instruments Suppliers in Kenya
Where can I find dental instruments suppliers in Kenya? +
GERATI Healthcare are ISO 13485-certified dental instruments suppliers in Kenya, manufacturing in Sialkot, Pakistan and supplying wholesale dental forceps, scalers, mirrors and probes direct to Nairobi distributors and Mombasa-based importers. MOQ from 50 units. CIF Mombasa shipping available. Request RFQ at gerati.com.
What documentation does GERATI provide for PPB Kenya registration? +
GERATI provides a complete manufacturer documentation package to support your PPB Kenya Class B product registration application — ISO 13485:2016 QMS certificate, CE Declaration of Conformity (MDR 2017/745), Certificate of Origin (COO), Product Technical File, Instructions for Use (IFU), and Packing List with HS Code 9018.49. PPB registration is completed by the Kenyan importer using these manufacturer documents. All documentation is provided at no additional charge.
How long does shipping from Pakistan to Kenya take? +
Sea freight from Karachi to Mombasa takes 18–25 days. Air freight to JKIA Nairobi takes 5–7 days. CIF Mombasa, FOB Karachi, and EXW Sialkot Incoterms available. Production lead time is 3–5 weeks from confirmed order.
What is the minimum order quantity for Kenya? +
MOQ is 50 units per product family for wholesale orders. Sample orders of 5–10 units are available for first-time Kenyan distributors. Payment: 30% TT advance + 70% on Bill of Lading, or LC at sight.
Are GERATI instruments ISO 13485 and CE certified? +
Yes. GERATI instruments are manufactured under ISO 13485:2016 quality management system and carry CE Marking under MDR 2017/745. These are internationally recognised manufacturer certifications accepted as the basis for medical device registration across African regulatory bodies including PPB Kenya, TFDA Tanzania, NDA Uganda, and others.
Can GERATI supply OEM private label dental instruments for Kenya? +
Yes. GERATI offers full OEM and private label manufacturing for Kenyan distributors. Custom branding, packaging, and ISO 13485 OEM documentation are available. Contact sales@gerati.com to discuss your requirements.
With 25+ years in certified surgical and dental instrument manufacturing in Sialkot, Aqeel Abbas oversees GERATI Healthcare’s ISO 13485 quality management operations. Expert knowledge of CE MDR compliance and East African medical device import requirements — supporting Kenyan and African importers with complete manufacturer documentation for local regulatory registration.
Dental Instruments Suppliers in Kenya — Request a Wholesale Quote
Factory-direct from Sialkot Pakistan · ISO 13485 & CE MDR certified · Full manufacturer documentation for PPB Kenya · CIF Mombasa · Response within 24 business hours
📍 Sialkot, Pakistan
🌐 www.gerati.com