Identity
- Trade Name
- Bougie Dilator Sets EUDAMED
- Device Name
- Bougie Dilator Sets EUDAMED
- Model / Reference
- FST-K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957024905641 EUDAMED
- Basic UDI-DI
- 695702496601KN EUDAMED
- Direct Marketing DI
- 06957024905641 EUDAMED
- EMDN Code
- G03010202 DIGESTIVE ENDOSCOPY, PROGRESSIVE FLEXIBLE DILATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
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
The Bougie Dilator Sets are a high-quality, clinical-grade dilators designed for surgical use. These sets are precision-engineered to provide optimal results in minimally invasive procedures, with features such as sterile sterilization and precise cutting capabilities. Made by Creo Medical, S.L.U., these dilators are suitable for various applications, including orthopedic, urological, and ophthalmological surgeries.
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 | 695702496601KN | 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 9727688e-31ae-41b7-9765-f2ba1d763485 61 fields · synced Jul 24, 2026