Identity
- Trade Name
- Fielmann FDA UDI
- Generic Name
- Spectacle frame FDA UDI
- Model / Reference
- LN 043 RN ADRIAN_27462 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04066209050396 FDA UDI
- FDA Product Code
- HQZ FDA UDI
- GMDN Term
- Spectacle frame FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5842 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Spectacle frame
A comprehensive ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user, typically consisting of a plastic or metallic frame supported by the nose and ears. It may have a protective function.
Similar devices
Also classified as Spectacle frame.
- BBIG — BBig B.V. · Class I
- Fysh — WestGroupe Optical Inc · Class I
- BBIG — BBig B.V. · Class I
- BBIG — BBig B.V. · Class I
- Kliik:denmark Eyewear — WestGroupe Optical Inc · Class I
- BBIG — BBig B.V. · Class I
- EYEWEAR BY ROI WOODBURY BROWN — Eyewear By Roi, Limited · Class I
- Daniel Hechter — MPG GmbH · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fielmann Group AG
Sources (1)
- FDA UDI efc738fd-55cc-4807-9684-de4ed38d0433 32 fields · synced Jul 20, 2026