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Stent application system
EUDAMEDClass I (EU MDR)
Ref DISS08URef DISS07URef DISS05U
Identity
- Trade Name
- Stent application system EUDAMED
- Device Name
- Stent application system EUDAMED
- Model / Reference
- DISS08U EUDAMEDDISS07U EUDAMEDDISS05U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05420051300600 EUDAMED05420051300587 EUDAMED05420051302932 EUDAMED
- Basic UDI-DI
- 54200513-TF06-PSH-SU-LA EUDAMED
- EMDN Code
- P058001 OESOPHAGEAL AND GASTROINTESTINAL PROSTHESES POSITIONING DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Stent application system by G-Flex Flexible Instruments Europe — 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 | 54200513-TF06-PSH-SU-LA | Class I | Active |
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Manufacturer
- Manufacturer
- G-Flex Flexible Instruments Europe
- EUDAMED SRN
- BE-MF-000000623
Sources (3)
- EUDAMED bba9fb91-189f-469f-95f8-1d91a80806c7 61 fields · synced Jul 10, 2026
- EUDAMED 027f87e6-50db-4342-b2cc-3563191279c8 61 fields · synced May 17, 2026
- EUDAMED 392b22c1-b2e8-442f-947f-79f2254931cb 61 fields · synced May 18, 2026