Identity
- Trade Name
- OFA EUDAMEDNA FDA UDI
- Generic Name
- Perimeter, automatic FDA UDI
- Device Name
- ObjectiveFIELD Analyzer EUDAMED
- Model / Reference
- OFA-001 EUDAMEDFDA UDIPR-OFA-A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582275270075 EUDAMEDFDA UDI
- Basic UDI-DI
- 458227526KONAN-OPELW EUDAMED
- Direct Marketing DI
- 04582275270075 EUDAMED
- FDA Product Code
- HPT FDA UDI
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMED
- GMDN Term
- Perimeter, automatic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1605 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Ofa by Konan Medical Usa, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 458227526KONAN-OPELW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Konan Medical Usa, Inc.
- EUDAMED SRN
- US-MF-000014687
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 6313f690-5729-4053-9548-f2e1be60230f 61 fields · synced Jul 27, 2026
- FDA UDI 76768d36-4fd6-4b27-8034-2f009e67e9ef 32 fields · synced May 27, 2026