Identity
- Trade Name
- Disposable Ear Specula EUDAMED
- Device Name
- Disposable Ear Specula EUDAMED
- Model / Reference
- Disposable Ear Specula EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976337770135 EUDAMED
- Basic UDI-DI
- 697633777120P6 EUDAMED
- Direct Marketing DI
- 06976337770135 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
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
Disposable Ear Specula 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 | 697633777120P6 | 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 (1)
- EUDAMED e14ba7ec-907f-4ef2-b4c5-bcafc61c4160 61 fields · synced Jul 13, 2026