Identity
- Trade Name
- OT8k otoscope EUDAMEDOT8K EUDAMED
- Device Name
- otoscope EUDAMED
- Model / Reference
- / EUDAMED462-1810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945095507314 EUDAMED06945095544180 EUDAMED
- Basic UDI-DI
- 69450955otoscopeTK EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMEDZ12149006 DIRECT OUTPATIENT OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Otoscope, endoscopic
OT8k otoscope by Zumax Medical Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Otoscope, endoscopic.
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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 | 69450955otoscopeTK | Class I | Active |
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Manufacturer
- Manufacturer
- Zumax Medical CO., LTD.
- EUDAMED SRN
- CN-MF-000011126
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED c0c4b4cc-c3fb-4add-a425-695ca5c2edd5 61 fields · synced Jul 9, 2026
- EUDAMED 1dec02fe-c55c-4f3a-8939-13c9d1ae1fda 61 fields · synced Jun 18, 2026