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Stone Extraction Balloons
EUDAMEDClass IIa (EU MDR)
Ref FST-BAL-23-10/13/16-BRef FST-BAL-23-11/13/15-BRef FST-BAL-23--BRef FST-BAL-23-9/12/15-BRef FST-BAL-23-8.5/11.5/15-B
Identity
- Trade Name
- Stone Extraction Balloons EUDAMED
- Device Name
- Stone Extraction Balloons EUDAMED
- Model / Reference
- FST-BAL-23-10/13/16-B EUDAMEDFST-BAL-23-11/13/15-B EUDAMEDFST-BAL-23--B EUDAMEDFST-BAL-23-9/12/15-B EUDAMEDFST-BAL-23-8.5/11.5/15-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957024906631 EUDAMED06957024910737 EUDAMED06957024905597 EUDAMED06957024911055 EUDAMED06957024906228 EUDAMED
- Basic UDI-DI
- 695702495301JY EUDAMED
- Direct Marketing DI
- 06957024906631 EUDAMED06957024910737 EUDAMED06957024905597 EUDAMED06957024911055 EUDAMED06957024906228 EUDAMED
- EMDN Code
- G03050101 DIGESTIVE ENDOSCOPY, RETRIEVAL BALLOON DEVICES 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
Yes
EUDAMEDEUDAMED
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
Stone Extraction Balloons 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 | 695702495301JY | 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 (5)
- EUDAMED d8f186f2-3a90-479b-93cd-81e7fcbbc2d3 61 fields · synced Jul 21, 2026
- EUDAMED 1c894aab-154d-49a5-9dce-f02839a72dd5 61 fields · synced May 16, 2026
- EUDAMED 9f2a4f6f-643a-4140-a23d-afdf3a845744 61 fields · synced May 16, 2026
- EUDAMED 24dae254-8388-44ef-a3fa-cc5db46a2126 61 fields · synced May 16, 2026
- EUDAMED f07b602c-8163-4426-8f4b-e43da46abd5a 61 fields · synced May 18, 2026