Identity
- Trade Name
- Balloon Inflators EUDAMED
- Device Name
- Balloon Inflators EUDAMED
- Model / Reference
- FST-IF-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957024911826 EUDAMED
- Basic UDI-DI
- 695702496402KE EUDAMED
- Direct Marketing DI
- 06957024911826 EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Balloon Inflators by Foresight Technology Co., Ltd. — Class I — 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 | 695702496402KE | Class I | 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 604d5972-72ed-46af-bbab-ac980b2d49da 61 fields · synced Jun 19, 2026