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Swivel Flex Tube
EUDAMEDClass IIa (EU MDR)
Ref G-312004-ENModel G-312004Ref G-312001-ENModel G-312001Ref G-312008-ENModel G-312008
Identity
- Trade Name
- Swivel Flex Tube EUDAMED
- Device Name
- Swivel Flex Tube EUDAMED
- Model / Reference
- G-312004 EUDAMEDG-312004-EN EUDAMEDG-312001 EUDAMEDG-312001-EN EUDAMEDG-312008 EUDAMEDG-312008-EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719875343698 EUDAMED04719875343667 EUDAMED04719875343728 EUDAMED
- Basic UDI-DI
- B-04719875343698 EUDAMEDB-04719875343667 EUDAMEDB-04719875343728 EUDAMED
- EMDN Code
- R020202 MOBILE CATHETER MOUNTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovakia EUDAMED
Clinical & Handling
Sterile
No
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
Swivel Flex Tube by VADI Medical 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-04719875343698 | Class IIa | Active |
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Manufacturer
- Manufacturer
- VADI Medical Technology Co., Ltd.
- EUDAMED SRN
- TW-MF-000022930
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (3)
- EUDAMED 47aae77a-a035-4486-b972-b8bd33eb942b 61 fields · synced Jul 26, 2026
- EUDAMED 00fb50b5-148f-48f9-b242-92c0e38828cf 61 fields · synced May 17, 2026
- EUDAMED 01307d32-2f32-4ef5-8811-2939b59762d8 61 fields · synced May 19, 2026