I/A Handpiece
by Duckworth & Kent Ltd. United Kingdom EUDAMEDGUDID
Ref 8-711N
Product code HMXEMDN L179004
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-05055313823407 | Date24 Sep 2025 | StatusActive |
| United States | GUDID listing GUDID | Number05055313823407 | Date31 Aug 2022 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Duckworth & Kent
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
- Model / Ref / Catalog
- 8-711N
- Primary DI / UDI-DI
- 05055313823407
- Basic UDI-DI
- B-05055313823407
- FDA Product Code
- HMX
- EMDN Code
- L179004 Ocular irrigation or suction handpieces, reusable
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 886.4350
- Market of Registration
- Italy
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- GB-MF-000002176
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Duckworth & Kent Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (18)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
Sources (2)
- EUDAMED f64491f8-e0f5-4092-9cc2-f9fa62fa73d5
- FDA UDI ef807630-da84-47ef-881f-bcc643d8e692