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Gastrointestinal And Biliary Balloon Catheters
EUDAMEDClass IIa (EU MDR)
Ref FST-BD-06-40-200Ref FST-BD-20-80-230Ref FST-BD-20-80-180Ref FST-BD-25-80-90Ref FST-BD-40-80-90Ref FST-BD-30-80-90Model FST-BD-30--90Ref FST-BD-35-80-90Ref FST-BD-12-60-200Ref FST-BD-20-60-180
Identity
- Trade Name
- Gastrointestinal And Biliary Balloon Catheters EUDAMED
- Device Name
- Gastrointestinal And Biliary Balloon Catheters EUDAMED
- Model / Reference
- FST-BD-06-40-200 EUDAMEDFST-BD-20-80-230 EUDAMEDFST-BD-20-80-180 EUDAMEDFST-BD-25-80-90 EUDAMEDFST-BD-40-80-90 EUDAMEDFST-BD-30--90 EUDAMEDFST-BD-30-80-90 EUDAMEDFST-BD-35-80-90 EUDAMEDFST-BD-12-60-200 EUDAMEDFST-BD-20-60-180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957024904781 EUDAMED06957024904743 EUDAMED06957024904729 EUDAMED06957024904750 EUDAMED06957024906099 EUDAMED06957024904767 EUDAMED06957024904774 EUDAMED06957024904804 EUDAMED06957024904712 EUDAMED
- Basic UDI-DI
- 695702494610K9 EUDAMED695702494605KG EUDAMED695702494604KE EUDAMED695702494606KJ EUDAMED695702494609KQ EUDAMED695702494607KL EUDAMED695702494608KN EUDAMED695702494612KD EUDAMED
- Direct Marketing DI
- 06957024904781 EUDAMED06957024904743 EUDAMED06957024904729 EUDAMED06957024904750 EUDAMED06957024906099 EUDAMED06957024904767 EUDAMED06957024904774 EUDAMED06957024904804 EUDAMED06957024904712 EUDAMED
- EMDN Code
- G0301010401 BILIARY BALLOON CATHETERS, LOW PRESSURE EUDAMEDG0301010101,G0301010301,G03010199 EUDAMEDG0301010101,G0301010301,G0301010501 EUDAMEDG0301010201 ACHALASIA BALLOON CATHETERS, LOW PRESSURE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDGreece 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 | 695702494610K9 | 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 (9)
- EUDAMED 6047ba8c-e527-4430-bd3c-49c26166941e 61 fields · synced Sep 18, 2026
- EUDAMED 69139d96-7ca0-4366-bb51-ee8c9d240d60 61 fields · synced May 17, 2026
- EUDAMED 3369a7fa-45cf-4e8b-aa2d-5a71b44bc063 61 fields · synced May 17, 2026
- EUDAMED 46428954-a185-40a8-9d00-c165888c2a8e 61 fields · synced May 17, 2026
- EUDAMED 2cc31fc2-ef81-432c-b2ee-7b65206550bb 61 fields · synced May 17, 2026
- EUDAMED 415faaf0-fa6c-4acc-9267-4a444a423a69 61 fields · synced May 18, 2026
- EUDAMED 08fb8ef1-f24b-4f2b-ac24-d0cfc8c75e67 61 fields · synced May 18, 2026
- EUDAMED 9b2a2bc6-8f5f-4a77-a5a9-e01b2917022f 61 fields · synced May 18, 2026
- EUDAMED 9ac099cd-42d8-4119-8cf7-99dc95981df8 61 fields · synced May 19, 2026