Identity
- Trade Name
- Duckworth & Kent FDA UDI
- Generic Name
- Ophthalmic curette, reusable FDA UDI
- Device Name
- Chalazion Curette EUDAMEDFDA UDI
- Model / Reference
- 6-641-3 EUDAMEDFDA UDI
- Description
- Chalazion Curette FDA UDI
Identifiers
- Catalog Number
- 6-641-3 FDA UDI
- Primary DI / UDI-DI
- 05055313810360 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055313810360 EUDAMED
- FDA Product Code
- HNZ FDA UDI
- EMDN Code
- L1703 OPHTHALMOLOGY CURETTES, REUSABLE EUDAMED
- GMDN Term
- Ophthalmic curette, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 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
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
Category: Ophthalmic curette, reusable
Chalazion Curette by Duckworth & Kent Ltd. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-05055313810360 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Duckworth & Kent Ltd.
- EUDAMED SRN
- GB-MF-000002176
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 3759c238-1e0b-4551-ac25-114e796dfac3 61 fields · synced Jul 9, 2026
- FDA UDI cf411f71-133f-4798-8b23-b7d268a11452 36 fields · synced May 30, 2026