Identity
- Trade Name
- Oivi Opthalmic Fundus Camera FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- The OFC100L is a high-resolution ophthalmic imaging device that is primarily intended for photographing the fundus of the eye with / without dilating the pupil. It is a prescription-use medical device only. FDA UDI
- Model / Reference
- OFC100L FDA UDI
- Description
- The OFC100L is a high-resolution ophthalmic imaging device that is primarily intended for photographing the fundus of the eye with / without dilating the pupil. It is a prescription-use medical device only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010826812 FDA UDI
- FDA Product Code
- PJZ FDA UDI
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1120 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic fundus camera
Oivi Opthalmic Fundus Camera by Oivi AS — 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
- Oivi AS
Sources (1)
- FDA UDI 076db03f-587f-47ba-ae04-b057281503d6 35 fields · synced May 30, 2026