Identity
- Trade Name
- Bedal Flex M EUDAMEDBedal FDA UDI
- Generic Name
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
- Device Name
- Sterile, single use patches for stabilization of catheters, tubing, and cables EUDAMEDSterilized FDA UDI
- Model / Reference
- FlexGRIP EUDAMEDUN-FLEX-M EUDAMEDbedal flex M FDA UDI
- Description
- Sterilized FDA UDI
Identifiers
- Catalog Number
- UN-FLEX-M FDA UDI
- Primary DI / UDI-DI
- 05430000258807 EUDAMEDFDA UDI
- Basic UDI-DI
- 5430000258FlexGRIPSAF EUDAMED
- FDA Product Code
- KGZ FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 94.1 Millimeter FDA UDIWidth — 38.8 Millimeter FDA UDIHeight — 9.6 Millimeter FDA UDI
Category: Device sterilization/disinfection container, reusable
Bedal Flex M by Bedal International — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5430000258FlexGRIPSAF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bedal International
- EUDAMED SRN
- BE-MF-000001242
Sources (2)
- EUDAMED 7a6f1151-0ceb-4745-9d17-0055e218b712 61 fields · synced Jun 18, 2026
- FDA UDI 49c0fece-17b7-4505-85b2-154c3e8b3d11 37 fields · synced May 30, 2026