Identity
- Trade Name
- Fiber Optic Otoscope (Pocket Style) EUDAMED
- Device Name
- Fiber Optic Otoscope (Pocket Style) EUDAMED
- Model / Reference
- 500-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++G21550010 EUDAMED
- Basic UDI-DI
- ++G21550010F8 EUDAMED
- Direct Marketing DI
- ++G21550010 EUDAMED
- EMDN Code
- Z12149006 DIRECT OUTPATIENT OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Fiber Optic Otoscope (Pocket Style) by UAMED Surgical Industries — 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 | ++G21550010F8 | Class I | Active |
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Manufacturer
- Manufacturer
- UAMED Surgical Industries
- EUDAMED SRN
- PK-MF-000029358
- Authorised Representative
- Yellow's medical instruments GmbH DE-AR-000007390
Sources (1)
- EUDAMED dde7bca2-90eb-44f2-a28b-3a4cb88ee253 61 fields · synced Aug 3, 2026