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Oftalmoscopio F.o. Sigma - 2, 5v - Led
EUDAMEDClass I (EU MDR)
Ref 31529Model OFTALMOSCOPI
by Gima Spa
Identity
- Trade Name
- OFTALMOSCOPIO F.O. SIGMA - 2,5V - LED EUDAMED
- Device Name
- OFTALMOSCOPI EUDAMED
- Model / Reference
- OFTALMOSCOPI EUDAMED31529 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08023279315295 EUDAMED
- Basic UDI-DI
- 8023279Z121201140000000Q9 EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Oftalmoscopio F.o. Sigma - 2, 5v - Led by Gima Spa — 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 | 8023279Z121201140000000Q9 | Class I | Active |
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Manufacturer
- Manufacturer
- Gima Spa
- EUDAMED SRN
- IT-MF-000011004
Sources (1)
- EUDAMED c22b4b2b-964e-4c81-a35a-2d0d5f860606 61 fields · synced Jul 9, 2026