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4K Medical Endoscope Camera System
EUDAMEDClass I (EU MDR)
Ref SZ-8080Model SZ-8098，SZ-8088，SZ-8080，SZ-8068
Identity
- Trade Name
- 4K Medical Endoscope Camera System EUDAMED
- Device Name
- 4K Medical Endoscope Camera System EUDAMED
- Model / Reference
- SZ-8098，SZ-8088，SZ-8080，SZ-8068 EUDAMEDSZ-8080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976042830087 EUDAMED
- Basic UDI-DI
- 697604283SZ-4KCAM7S EUDAMED
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED
Classification
- Device Class
- Class I 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 Medical Endoscope Camera System by Jiangxi China Medical Equipment 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 | 697604283SZ-4KCAM7S | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangxi China Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000037457
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED abfcde48-5d5f-4d20-a98b-8834f50fecac 61 fields · synced Jun 18, 2026