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4K UHD Sinuscope
EUDAMEDClass I (EU MDR)
Ref 4K4000RModel 4K4000、4K4030、4K4070 4K4000R、4K4030R、4K4070R
Identity
- Trade Name
- 4K UHD Sinuscope EUDAMED
- Device Name
- 4K UHD Sinuscope EUDAMED
- Model / Reference
- 4K4000、4K4030、4K4070 4K4000R、4K4030R、4K4070R EUDAMED4K4000R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381250343 EUDAMED
- Basic UDI-DI
- 697138125006A8E EUDAMED
- Direct Marketing DI
- 06971381250343 EUDAMED
- EMDN Code
- Z12021101 ARTHROSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
4K UHD Sinuscope by Scivita Medical Technology Co., Ltd. — Class I — 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 | 697138125006A8E | Class I | Active |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f5625cd4-895c-4f90-82b1-6261a29cdae6 61 fields · synced Jun 17, 2026