Identity
- Device Name
- Oto. 040.00.0295 EUDAMED
- Model / Reference
- 9ALA-1004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-9ALA-1004F4 EUDAMED
- Basic UDI-DI
- B-9ALA-1004F4 EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Otoscope, endoscopic
Oto. 040.00.0295 by Blazejewski MEDI-TECH GmbH — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-9ALA-1004F4 | Class I | Active |
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Manufacturer
- Manufacturer
- Blazejewski MEDI-TECH GmbH
- EUDAMED SRN
- DE-MF-000005467
Sources (1)
- EUDAMED d2984f3b-abbd-44b6-bdf9-2831c697ef12 61 fields · synced Jun 18, 2026