Identity
- Trade Name
- Robert La Roche FDA UDI
- Generic Name
- Spectacle frame FDA UDI
- Model / Reference
- RLR1140-03 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09010491032160 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
Yes
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
Category: Spectacle frame
The Robert La Roche spectacle frame is an innovative ophthalmic device designed to provide a comfortable and secure fit for users. Its unique plastic or metallic frame supports the nose and ears, allowing it to hold pairs of spectacle lenses in place. The device also features side shields for added protection.
Similar devices
Also classified as Spectacle frame.
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- Kliik:denmark Eyewear — WestGroupe Optical Inc · Class I
- BBIG — BBig B.V. · Class I
- Fielmann — Fielmann Group AG · 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
- RLR eyewear GesmbH
Sources (1)
- FDA UDI b4c38b33-9fe1-4f5c-891d-00a4e46a18f9 32 fields · synced Jul 30, 2026