Identity
- Trade Name
- Fysh FDA UDI
- Generic Name
- Spectacle frame FDA UDI
- Model / Reference
- F-3539 SNOW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00676190252255 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
The Fysh is an innovative ophthalmic device designed to securely hold a pair of spectacle lenses in front of and close to the eyes, typically consisting of a plastic or metallic frame that is supported by the nose and ears. This device offers improved user experience and enhances eye care.
Similar devices
Also classified as Spectacle frame.
- Fielmann — Fielmann Group AG · Class I
- BBIG — BBig B.V. · Class I
- BBIG — BBig B.V. · Class I
- BBIG — BBig B.V. · Class I
- BBIG — BBig B.V. · Class I
- Fielmann — Fielmann Group AG · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- WestGroupe Optical Inc
Sources (1)
- FDA UDI 8b91d7b7-c14c-4da0-9555-b7b7e7eed171 32 fields · synced Jul 12, 2026