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4K UHD Sinuscope
EUDAMEDClass I (EU MDR)
Ref 4K4070Model 4K4000、4K4030、4K4070 4K4000R、4K4030R、4K4070RRef 4K4000Ref 4K4030RRef 4K4070RRef 4K4030
Identity
- Trade Name
- 4K UHD Sinuscope EUDAMED
- Device Name
- 4K UHD Sinuscope EUDAMED
- Model / Reference
- 4K4000、4K4030、4K4070 4K4000R、4K4030R、4K4070R EUDAMED4K4070 EUDAMED4K4000 EUDAMED4K4030R EUDAMED4K4070R EUDAMED4K4030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381250336 EUDAMED06971381250312 EUDAMED06971381250350 EUDAMED06971381250367 EUDAMED06971381250329 EUDAMED
- Basic UDI-DI
- 697138125006A8E EUDAMED
- Direct Marketing DI
- 06971381250336 EUDAMED06971381250312 EUDAMED06971381250350 EUDAMED06971381250367 EUDAMED06971381250329 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 (5)
- EUDAMED bec22396-be89-40a1-8215-c44ae733073b 61 fields · synced Jul 31, 2026
- EUDAMED 0e52c51a-ba3a-4e26-83ee-2b86b2b53538 61 fields · synced May 11, 2026
- EUDAMED ef2a97fe-0ba3-4301-982a-4c55a2244493 61 fields · synced May 16, 2026
- EUDAMED 1fdc8663-4040-4518-8867-225dd6af0918 61 fields · synced May 17, 2026
- EUDAMED ce915f4f-9049-46a0-bd7e-7955b778f206 61 fields · synced May 19, 2026