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FlexGRIP Universal 11-18 Fr (distributed by Cook)
EUDAMEDClass I (EU MDR)
Ref FLEXM-10; FLEXM-50Model FlexGRIP
Identity
- Trade Name
- FlexGRIP Universal 11-18 Fr (distributed by Cook) EUDAMED
- Device Name
- Sterile, single use patches for stabilization of catheters, tubing, and cables EUDAMED
- Model / Reference
- FlexGRIP EUDAMEDFLEXM-10; FLEXM-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05430003674055 EUDAMED
- Basic UDI-DI
- 5430000258FlexGRIPSAF EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER 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
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
FlexGRIP Universal 11-18 Fr (distributed by Cook) by Bedal International — 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 | 5430000258FlexGRIPSAF | Class I | Active |
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Manufacturer
- Manufacturer
- Bedal International
- EUDAMED SRN
- BE-MF-000001242
Sources (2)
- EUDAMED ace79c96-86bd-465e-9c7f-6c9e94120266 61 fields · synced Jul 11, 2026
- EUDAMED ace79c96-86bd-465e-9c7f-6c9e94120266-1 61 fields · synced Jun 10, 2026