Identity
- Trade Name
- Duckworth & Kent FDA UDI
- Generic Name
- Manual intraocular lens injector, reusable FDA UDI
- Device Name
- Implantation System EUDAMEDFDA UDI
- Model / Reference
- DK7786 EUDAMEDFDA UDI
- Description
- Implantation System FDA UDI
Identifiers
- Catalog Number
- DK7786 FDA UDI
- Primary DI / UDI-DI
- 05055313821632 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055313821632 EUDAMED
- FDA Product Code
- KYB FDA UDI
- EMDN Code
- L1709 OCULAR IMPLANT INSTRUMENTS NOT INCLUDED IN OTHER CLASSES, REUSABLE EUDAMED
- GMDN Term
- Manual intraocular lens injector, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Implantation System by Duckworth & Kent Ltd. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05055313821632 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Duckworth & Kent Ltd.
- EUDAMED SRN
- GB-MF-000002176
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 87ec855f-e3dc-4493-a433-614c0bbf67c9 61 fields · synced Jul 9, 2026
- FDA UDI d0aa0ae2-3f06-423f-a160-d4c6ed704504 36 fields · synced May 27, 2026