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ENT ENDOSCOPY INSTRUMENTS(Otoscope)
EUDAMEDClass IIa (EU MDR)
Ref C0013AModel /
Identity
- Device Name
- ENT ENDOSCOPY INSTRUMENTS(Otoscope) EUDAMED
- Model / Reference
- / EUDAMEDC0013A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945014218697 EUDAMED
- Basic UDI-DI
- 69450142Z120210073E EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
ENT ENDOSCOPY INSTRUMENTS(Otoscope) by Zhejiang Tiansong Medical Instrument Co., Ltd — Class IIa — 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 | 69450142Z120210073E | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Tiansong Medical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000008834
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 78223924-d3f2-49ff-9827-c0545bd66ea0 61 fields · synced Jul 18, 2026