Identity
- Trade Name
- Stone Extraction Balloons EUDAMED
- Device Name
- Stone Extraction Balloons EUDAMED
- Model / Reference
- VDK-BAL-23-15/18/20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970057571041 EUDAMED
- Basic UDI-DI
- B-06970057571041 EUDAMED
- EMDN Code
- G03050101 DIGESTIVE ENDOSCOPY, RETRIEVAL BALLOON DEVICES 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
Yes
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Stone Extraction Balloons by Jiangsu Vedkang Medical Science and Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970057571041 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000008462
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED a98e2789-24f6-4c14-a183-820ee9d3aa25 61 fields · synced Oct 7, 2026