← Back to catalogue
OTO-OFTALMOSCOPIO F.O. SIGMA A LED con 2 manici - in astuccio rigido
EUDAMEDClass I (EU MDR)
Ref 31534Model OTO-OFTALMOSCOPI
by Gima Spa
Identity
- Trade Name
- OTO-OFTALMOSCOPIO F.O. SIGMA A LED con 2 manici - in astuccio rigido EUDAMED
- Device Name
- OTO-OFTALMOSCOPI EUDAMED
- Model / Reference
- OTO-OFTALMOSCOPI EUDAMED31534 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08023279315349 EUDAMED
- Basic UDI-DI
- 802327900L1603033500000V5 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
OTO-OFTALMOSCOPIO F.O. SIGMA A LED con 2 manici - in astuccio rigido 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 | 802327900L1603033500000V5 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gima Spa
- EUDAMED SRN
- IT-MF-000011004
Sources (1)
- EUDAMED de4cdc72-bcc2-44bb-aa49-2af7b7781548 61 fields · synced Jun 19, 2026