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Portable Endoscopy Camera Unit
EUDAMEDClass I (EU MDR)
Ref SY-GW612Ref SY-GW617
Identity
- Trade Name
- Portable Endoscopy Camera Unit EUDAMED
- Device Name
- Portable Endoscopy Camera Unit EUDAMED
- Model / Reference
- SY-GW612 EUDAMEDSY-GW617 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975422140068 EUDAMED06975422140075 EUDAMED
- Basic UDI-DI
- 697542214SY-GW612000001SA EUDAMED697542214SY-GW617000001UX EUDAMED
- Direct Marketing DI
- 06975422140068 EUDAMED06975422140075 EUDAMED
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Portable Endoscopy Camera Unit by Anhui Youtak Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697542214SY-GW612000001SA | Class I | Active |
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Manufacturer
- Manufacturer
- Anhui Youtak Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000026531
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (2)
- EUDAMED 09adf6f9-1933-488c-8312-7266df081f89 61 fields · synced Jul 26, 2026
- EUDAMED efd31604-2b83-4c61-82b1-c3f816de8c43 61 fields · synced May 17, 2026