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FlexGRIP Universal 11-18 Fr
EUDAMEDClass I (EU MDR)
Ref UN1118-CAPModel FlexGRIP
Identity
- Trade Name
- FlexGRIP Universal 11-18 Fr EUDAMED
- Device Name
- Sterile, single use patches for stabilization of catheters, tubing, and cables EUDAMED
- Model / Reference
- FlexGRIP EUDAMEDUN1118-CAP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05430000258753 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
Category: Device sterilization/disinfection container, reusable
FlexGRIP Universal 11-18 Fr by Bedal International — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (1)
- EUDAMED 5bf9962f-b550-4f50-bcc4-79d36a46432a 61 fields · synced Jun 19, 2026