Identity
- Trade Name
- Bougie Dilator Sets EUDAMED
- Device Name
- Bougie Dilator Sets EUDAMED
- Model / Reference
- FST-K-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957024910188 EUDAMED
- Basic UDI-DI
- 695702496602KQ EUDAMED
- Direct Marketing DI
- 06957024910188 EUDAMED
- EMDN Code
- G03010202 DIGESTIVE ENDOSCOPY, PROGRESSIVE FLEXIBLE DILATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Bougie Dilator Sets 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 | 695702496602KQ | 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 9dd5e800-2a54-40ac-ab9b-57baf02629f3 61 fields · synced Jun 18, 2026