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FlexGRIP Foley 11-18 Fr
EUDAMEDClass I (EU MDR)
Ref FOL1118-BModel FlexGRIPRef FOL1118-NS
Identity
- Trade Name
- FlexGRIP Foley 11-18 Fr EUDAMED
- Device Name
- Sterile, single use patches for stabilization of catheters, tubing, and cables EUDAMEDNon-sterile, single use patches for stabilization of catheters, tubing, and cables EUDAMED
- Model / Reference
- FlexGRIP EUDAMEDFOL1118-B EUDAMEDFOL1118-NS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05430004283782 EUDAMED05430003674765 EUDAMED
- Basic UDI-DI
- 5430000258FlexGRIPSAF EUDAMED5430000258FlexGRIPNSC9 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
EUDAMEDEUDAMED
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 Foley 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 (2)
- EUDAMED 3f99459b-dd2d-4de8-9daf-215aa55ebfaa 61 fields · synced Jul 16, 2026
- EUDAMED c6af4966-e40a-454e-bf47-988ea7a23c92 61 fields · synced May 18, 2026