Identity
- Trade Name
- Otoscope EUDAMED
- Device Name
- Otoscope EUDAMED
- Model / Reference
- 20.000.014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904507276195 EUDAMED
- Basic UDI-DI
- 590450727OT12EB EUDAMED
- EMDN Code
- Z12021007,Z12149006 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Otoscope by AUG MEDICAL Spółka z ograniczoną odpowiedzialnością — 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 | 590450727OT12EB | Class I | Active |
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Manufacturer
- Manufacturer
- AUG MEDICAL Spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000019086
Sources (1)
- EUDAMED 8b1c4ed3-a62d-44bc-88cf-af7d3cac513c 61 fields · synced Oct 7, 2026