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ENT ENDOSCOPY INSTRUMENTS(Otoscope)
EUDAMEDClass IIa (EU MDR)
Ref C0030.3Model /
Identity
- Device Name
- ENT ENDOSCOPY INSTRUMENTS(Otoscope) EUDAMED
- Model / Reference
- / EUDAMEDC0030.3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945014218864 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
Category: Otoscope, endoscopic
ENT ENDOSCOPY INSTRUMENTS(Otoscope) by Zhejiang Tiansong Medical Instrument Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 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 ca1aa403-ab65-4f4b-82a0-da1e260d8544 61 fields · synced Jun 19, 2026