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medical light source
EUDAMEDClass I (EU MDR)
Ref HCM 9688Model HCM 9693, HCM 9694,HCM 9695, HCM 9696, HCM 9697,HCM 9698, HCM 9699, HCM 9688, HCM 9888, HCM 9889, HCM 9912,HCM9913, HCM9914, HCM9915, HCM9916, HCM9917, HCM9918,HCM 9919, HCM9920, HCM9921
Identity
- Device Name
- medical light source EUDAMED
- Model / Reference
- HCM 9693, HCM 9694,HCM 9695, HCM 9696, HCM 9697,HCM 9698, HCM 9699, HCM 9688, HCM 9888, HCM 9889, HCM 9912,HCM9913, HCM9914, HCM9915, HCM9916, HCM9917, HCM9918,HCM 9919, HCM9920, HCM9921 EUDAMEDHCM 9688 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974193970010 EUDAMED
- Basic UDI-DI
- 697419397MLS001SU EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
medical light source by Nantong Healthcare Medical Instrument 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 | 697419397MLS001SU | Class I | Active |
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Manufacturer
- Manufacturer
- Nantong Healthcare Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000050033
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED fcc0d4c4-ff77-4d79-a420-0af57b7abf7e 61 fields · synced Jul 22, 2026