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UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope
EUDAMEDClass I (EU MDR)
Ref 4K-A1-102（A）Model 4K-A1-101（A）Ref HD-01-102 (A)Ref 4K-A1-101（D）Ref HD-01-101 (B)Ref HD-01-102 (B)Ref 4K-A1-103（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（A） EUDAMEDHD-01-102 (A) EUDAMED4K-A1-101（D） EUDAMEDHD-01-101 (B) EUDAMEDHD-01-102 (B) EUDAMED4K-A1-103（A） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949567064015 EUDAMED06949567072010 EUDAMED06949567063049 EUDAMED06949567071020 EUDAMED06949567072027 EUDAMED06949567063018 EUDAMED06949567065012 EUDAMED
- Basic UDI-DI
- 694956700001M6 EUDAMED
- Direct Marketing DI
- 06949567064015 EUDAMED06949567072010 EUDAMED06949567063049 EUDAMED06949567072027 EUDAMED06949567063018 EUDAMED06949567065012 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 (7)
- EUDAMED aa6a3862-3615-4382-b5be-35b251cd291d 61 fields · synced Jul 30, 2026
- EUDAMED f90a043e-2c12-4366-ae0f-dd8a4a557c05 61 fields · synced May 18, 2026
- EUDAMED 28eba2d9-2f62-45ba-807f-b4befc74f025 61 fields · synced May 18, 2026
- EUDAMED ccf97346-0462-4743-ae6d-a76b6be758f4 61 fields · synced May 18, 2026
- EUDAMED 2e51e695-1057-48d0-aedf-0683e6e96736 61 fields · synced May 18, 2026
- EUDAMED 0ebcb81d-daed-43f1-af91-9bdaa5bd437c 61 fields · synced May 19, 2026
- EUDAMED 1d68c1ec-db2c-4e02-bda9-394d9231e94a 61 fields · synced May 19, 2026