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ENT ENDOSCOPY INSTRUMENTS(Rhinoscope)
EUDAMEDClass IIa (EU MDR)
Ref B0412Model /
Identity
- Device Name
- ENT ENDOSCOPY INSTRUMENTS(Rhinoscope) EUDAMED
- Model / Reference
- / EUDAMEDB0412 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945014254459 EUDAMED
- Basic UDI-DI
- 69450142Z120210083G EUDAMED
- EMDN Code
- Z12021008 RHINOSCOPES 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(Rhinoscope) 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 | 69450142Z120210083G | 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 d85c5261-c027-40a6-8648-8771e0aa01a4 61 fields · synced Jun 18, 2026