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Fluorescent Light Source
EUDAMEDClass I (EU MDR)
Ref SZ-FL6080Model SZ-FL6098，SZ-FL6080，LC-980FL，LC-400FL
Identity
- Trade Name
- Fluorescent Light Source EUDAMED
- Device Name
- Fluorescent Light Source EUDAMED
- Model / Reference
- SZ-FL6098，SZ-FL6080，LC-980FL，LC-400FL EUDAMEDSZ-FL6080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976042830056 EUDAMED
- Basic UDI-DI
- 697604283SZ-FLLS27 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Category: Endoscopic light source unit, line-powered
Fluorescent Light Source by Jiangxi China Medical Equipment Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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-FLLS27 | 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 7784387d-b706-43f0-9608-615d56827ab0 61 fields · synced Jun 18, 2026