Identity
- Trade Name
- S4 OPTIK FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- COBRA FUNDUS CAMERA FDA UDI
- Model / Reference
- COBRA FDA UDI
- Description
- COBRA FUNDUS CAMERA FDA UDI
Identifiers
- Catalog Number
- 103303A00 V0/S10 FDA UDI
- Primary DI / UDI-DI
- 08056098470319 FDA UDI
- 510(k) Number
- K132987 FDA UDI
- FDA Product Code
- NFJ FDA UDIHKI FDA UDI
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI886.1120 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic fundus camera
S4 Optik by Costruzioni Strumenti Oftalmici C.s.o. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Costruzioni Strumenti Oftalmici C.s.o. Srl
Sources (1)
- FDA UDI e9804c6c-ea0b-48a2-9063-f78ad8c97489 35 fields · synced May 30, 2026