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LED Light Source
EUDAMEDClass I (EU MDR)
Ref SZ-GY2000Model SZ-GY2000、SZ-GY2600、SZ-GY2800、LC400Ref LC400Ref SZ-GY2600Ref SZ-GY2800
Identity
- Trade Name
- LED Light Source EUDAMED
- Device Name
- LED Light Source EUDAMED
- Model / Reference
- SZ-GY2000、SZ-GY2600、SZ-GY2800、LC400 EUDAMEDSZ-GY2000 EUDAMEDLC400 EUDAMEDSZ-GY2600 EUDAMEDSZ-GY2800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976042830513 EUDAMED06976042830544 EUDAMED06976042830520 EUDAMED06976042830537 EUDAMED
- Basic UDI-DI
- 697604283SZ-LEDLSFX 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
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
Category: Endoscopic light source unit, line-powered
LED 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-LEDLSFX | 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 (4)
- EUDAMED 36ec7f50-d5d1-4e14-a6bc-30390c22d59e 61 fields · synced Jul 25, 2026
- EUDAMED f113e268-aee4-40ac-8644-d60654416168 61 fields · synced May 17, 2026
- EUDAMED 2d90213d-1844-4954-bf3f-3bc91cbb2040 61 fields · synced May 18, 2026
- EUDAMED 902bbb98-b85b-4bcf-b09b-ef92aabbeba4 61 fields · synced May 19, 2026