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Bougie Dilator Sets
EUDAMEDClass I (EU MDR)
Ref FST-K-Ref FST-K-13Ref FST-K-11Ref FST-K-10Ref FST-K-17Ref FST-K-16Ref FST-K-8Ref FST-K-5Ref FST-K-18
Identity
- Trade Name
- Bougie Dilator Sets EUDAMED
- Device Name
- Bougie Dilator Sets EUDAMED
- Model / Reference
- FST-K- EUDAMEDFST-K-13 EUDAMEDFST-K-11 EUDAMEDFST-K-10 EUDAMEDFST-K-17 EUDAMEDFST-K-16 EUDAMEDFST-K-8 EUDAMEDFST-K-5 EUDAMEDFST-K-18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957024905931 EUDAMED06957024905979 EUDAMED06957024905962 EUDAMED06957024910171 EUDAMED06957024906020 EUDAMED06957024905993 EUDAMED06957024910164 EUDAMED06957024905948 EUDAMED06957024906037 EUDAMED
- Basic UDI-DI
- 695702496602KQ EUDAMED
- Direct Marketing DI
- 06957024905931 EUDAMED06957024905979 EUDAMED06957024905962 EUDAMED06957024910171 EUDAMED06957024906020 EUDAMED06957024905993 EUDAMED06957024910164 EUDAMED06957024905948 EUDAMED06957024906037 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 (9)
- EUDAMED c01da0c6-f788-456d-bd73-94a24bb71974 61 fields · synced Aug 3, 2026
- EUDAMED ac2fc397-ff87-4fae-b14e-fa3d9e0b6d86 61 fields · synced Jul 9, 2026
- EUDAMED 36387465-f1d3-4545-95ad-4cd93d47ccae 61 fields · synced Jul 10, 2026
- EUDAMED 5b476202-b154-4382-b01e-1ba781e8038f 61 fields · synced Jul 14, 2026
- EUDAMED b7a4e3d0-8638-424e-b173-5e64e6dfd591 61 fields · synced Jul 18, 2026
- EUDAMED d1bc4807-2379-4e0c-b0d7-e6742b4f7cd2 61 fields · synced Jul 19, 2026
- EUDAMED edf15e3f-52e0-4864-9eb4-137f0d404134 61 fields · synced Jul 22, 2026
- EUDAMED 8c76c01c-19df-4cab-b658-79943ccebde5 61 fields · synced Aug 3, 2026
- EUDAMED 1672a192-060d-49b5-aa67-770c6774376e 61 fields · synced Aug 3, 2026