Identity
- Trade Name
- Ophthalmoscope EUDAMED
- Device Name
- Ophthalmoscope EUDAMED
- Model / Reference
- FMO-001-9400-3090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004012709 EUDAMED
- Basic UDI-DI
- 8964003248OP038K EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Ophthalmoscope by SG Manufacturers — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8964003248OP038K | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SG Manufacturers
- EUDAMED SRN
- PK-MF-000007106
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED 776b3cb4-8742-4254-89db-daaea8d120b9 61 fields · synced Jul 31, 2026