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UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope
EUDAMEDClass I (EU MDR)
Ref 4K-A1-102（B）Model 4K-A1-101（A）
Identity
- Trade Name
- UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope EUDAMED
- Device Name
- UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope EUDAMED
- Model / Reference
- 4K-A1-101（A） EUDAMED4K-A1-102（B） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949567064022 EUDAMED
- Basic UDI-DI
- 694956700001M6 EUDAMED
- Direct Marketing DI
- 06949567064022 EUDAMED
- EMDN Code
- Z12020703 COLPOSCOPES 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
UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope by Guangdong Softlink Medical Innovation Co., Ltd. — Class I — MDR — listed in EUDAMED
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 | 694956700001M6 | Class I | Active |
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Manufacturer
- Manufacturer
- Guangdong Softlink Medical Innovation Co., Ltd.
- EUDAMED SRN
- CN-MF-000025833
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED d3dda072-4d97-4d33-b8d8-fe872db8e014 61 fields · synced Jun 17, 2026