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4K Fluorescent Medical Endoscope Camera System
EUDAMEDClass I (EU MDR)
Ref SZ-FL9080Model SZ-FL9088，SZ-FL9080，LC-6088FL，LC-6080FL
Identity
- Trade Name
- 4K Fluorescent Medical Endoscope Camera System EUDAMED
- Device Name
- 4K Fluorescent Medical Endoscope Camera System EUDAMED
- Model / Reference
- SZ-FL9088，SZ-FL9080，LC-6088FL，LC-6080FL EUDAMEDSZ-FL9080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976042830025 EUDAMED
- Basic UDI-DI
- 697604283SZ-FLCAMDU 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 Fluorescent 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-FLCAMDU | 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 b6ed9104-8fb6-43ab-9d4a-90303ab0240c 61 fields · synced Jun 19, 2026