Identity
- Trade Name
- Ureteral Access Sheathes EUDAMED
- Device Name
- Ureteral Access Sheathes EUDAMED
- Model / Reference
- VDK-USA-12450A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970057571492 EUDAMED
- Basic UDI-DI
- 697005757110HC EUDAMED
- EMDN Code
- U03010202 URETERAL DILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Ureteral Access Sheathes by Jiangsu Vedkang Medical Science and Technology Co., Ltd. — Class IIa — 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 | 697005757110HC | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000008462
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f6443b46-a0a5-431d-b2c7-bd5aa19acb2a 61 fields · synced Oct 5, 2026