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Gastrointestinal and Biliary Balloon Catheters
EUDAMEDClass IIa (EU MDR)
Ref VDK-BD-12-40-180
Identity
- Trade Name
- Gastrointestinal and Biliary Balloon Catheters EUDAMED
- Device Name
- Gastrointestinal and Biliary Balloon Catheters EUDAMED
- Model / Reference
- VDK-BD-12-40-180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970057572536 EUDAMED
- Basic UDI-DI
- B-06970057572536 EUDAMED
- EMDN Code
- G03010199 GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER 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
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
Gastrointestinal and Biliary Balloon Catheters by Jiangsu Vedkang Medical Science and Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED
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-06970057572536 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000008462
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED d3589aa3-b437-4f56-9cab-0b3b546aa990 61 fields · synced Oct 7, 2026