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Gastrointestinal And Biliary Balloon Catheters
EUDAMEDClass IIa (EU MDR)
Ref FST-BD-06-40-180
Identity
- Trade Name
- Gastrointestinal And Biliary Balloon Catheters EUDAMED
- Device Name
- Gastrointestinal And Biliary Balloon Catheters EUDAMED
- Model / Reference
- FST-BD-06-40-180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957024904682 EUDAMED
- Basic UDI-DI
- 695702494601K8 EUDAMED
- Direct Marketing DI
- 06957024904682 EUDAMED
- EMDN Code
- G0301010101,G0301010301,G03010199 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Gastrointestinal And Biliary Balloon Catheters by Foresight 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 | 695702494601K8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foresight Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009708
- Authorised Representative
- Creo Medical, S.L.U. ES-AR-000001355
Sources (1)
- EUDAMED 4f6516db-7895-4496-b0a9-d27c544fa934 61 fields · synced Jun 19, 2026