Identity
- Trade Name
- Duckworth & Kent FDA UDI
- Generic Name
- Lacrimal dilator, reusable FDA UDI
- Device Name
- Lacrimal Dilator EUDAMEDFDA UDI
- Model / Reference
- 6-180 EUDAMEDFDA UDI
- Description
- Lacrimal Dilator FDA UDI
Identifiers
- Catalog Number
- 6-180 FDA UDI
- Primary DI / UDI-DI
- 05055313809142 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055313809142 EUDAMED
- FDA Product Code
- HND FDA UDI
- EMDN Code
- L17010101 LACRIMAL DUCTS DILATORS, REUSABLE EUDAMED
- GMDN Term
- Lacrimal dilator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Lacrimal Dilator 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-05055313809142 | 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 d5b38e50-d7dc-49b0-81b1-83b8dec447a0 61 fields · synced Oct 6, 2026
- FDA UDI c7de1ba8-d626-4442-afbd-055095130ff8 35 fields · synced May 30, 2026