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4K UHD Arthroscope
EUDAMEDClass IIa (EU MDR)
Ref 4K4070Model 4K4000,4K4030,4K4070Ref 4K4000
Identity
- Trade Name
- 4K UHD Arthroscope EUDAMED
- Device Name
- 4K UHD Arthroscope EUDAMED
- Model / Reference
- 4K4000,4K4030,4K4070 EUDAMED4K4070 EUDAMED4K4000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381250305 EUDAMED06971381250282 EUDAMED
- Basic UDI-DI
- 697138125005A8B EUDAMED
- Direct Marketing DI
- 06971381250305 EUDAMED06971381250282 EUDAMED
- EMDN Code
- Z12021101 ARTHROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 Arthroscope by Scivita Medical Technology 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 | 697138125005A8B | Class IIa | 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 (2)
- EUDAMED 076019a6-518e-414c-b73f-939d79538733 61 fields · synced Jul 31, 2026
- EUDAMED 92e4c78b-036f-4a71-8f46-61838431684a 61 fields · synced May 17, 2026