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OTOSCOPIO F.O. SIGMA - LED - blu
EUDAMEDClass I (EU MDR)
Ref 31518Model OTOSCOPI
by Gima Spa
Identity
- Trade Name
- OTOSCOPIO F.O. SIGMA - LED - blu EUDAMED
- Device Name
- OTOSCOPI EUDAMED
- Model / Reference
- OTOSCOPI EUDAMED31518 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08023279315189 EUDAMED
- Basic UDI-DI
- 8023279Z1214900600000002X EUDAMED
- EMDN Code
- Z12149006 DIRECT OUTPATIENT OTOSCOPES 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
OTOSCOPIO F.O. SIGMA - LED - blu 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 | 8023279Z1214900600000002X | Class I | Active |
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Manufacturer
- Manufacturer
- Gima Spa
- EUDAMED SRN
- IT-MF-000011004
Sources (1)
- EUDAMED 3d067372-a031-4aea-9824-4d477b80d272 61 fields · synced Jul 30, 2026