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OTOVideo(Intelligent Digital Otoscope)
EUDAMEDClass I (EU MDR)
Ref QZ100, QZ101, QZ102, QZ103, QZ104, QZ105, QZ106, QZ107, QZ108
Identity
- Trade Name
- OTOVideo(Intelligent Digital Otoscope) EUDAMED
- Device Name
- OTOVideo(Intelligent Digital Otoscope) EUDAMED
- Model / Reference
- QZ100, QZ101, QZ102, QZ103, QZ104, QZ105, QZ106, QZ107, QZ108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976337770265 EUDAMED
- Basic UDI-DI
- 6976337770211ES EUDAMED
- Direct Marketing DI
- 06976337770265 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
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
OTOVideo(Intelligent Digital Otoscope) by Hangzhou Tingoton Technology 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 | 6976337770211ES | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Tingoton Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000042033
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (2)
- EUDAMED 2426d768-2d87-47cf-89c8-888136896f88 61 fields · synced Oct 6, 2026
- EUDAMED 2426d768-2d87-47cf-89c8-888136896f88-1 61 fields · synced Jun 10, 2026