Identity
- Trade Name
- Duckworth & Kent FDA UDI
- Generic Name
- Orbital depressor, reusable FDA UDI
- Device Name
- Scleral Depressor EUDAMEDFDA UDI
- Model / Reference
- 6-635-3 EUDAMEDFDA UDI
- Description
- Scleral Depressor FDA UDI
Identifiers
- Catalog Number
- 6-635-3 FDA UDI
- Primary DI / UDI-DI
- 05055313810278 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055313810278 EUDAMED
- FDA Product Code
- HNX FDA UDI
- EMDN Code
- L1705 OPHTHALMOLOGY PROBES, REUSABLE EUDAMED
- GMDN Term
- Orbital depressor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Italy 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
Scleral Depressor 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-05055313810278 | 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 57b1ddf5-ed8c-4173-8148-d437cb6fbbda 61 fields · synced Oct 6, 2026
- FDA UDI 3ad76c95-c8f1-4ddf-99ba-b0b1395b4db0 35 fields · synced May 24, 2026