Bedal Flex XS NON STERILE
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Bedal Flex XS NON STERILE EUDAMEDBedal FDA UDI
- Generic Name
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
- Device Name
- Non-sterile, single use patches for stabilization of catheters, tubing, and cables EUDAMEDNon Sterilized FDA UDI
- Model / Reference
- FlexGRIP EUDAMEDUN-FLEX-XS-NS EUDAMEDbedal flex XS FDA UDI
- Description
- Non Sterilized FDA UDI
Identifiers
- Catalog Number
- UN-FLEX-NS-XS FDA UDI
- Primary DI / UDI-DI
- 05430000258968 EUDAMEDFDA UDI
- Basic UDI-DI
- 5430000258FlexGRIPNSC9 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
No
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 — 93.9 Millimeter FDA UDIWidth — 38.8 Millimeter FDA UDIHeight — 6.3 Millimeter FDA UDI
Category: Device sterilization/disinfection container, reusable
Bedal Flex XS NON STERILE by Bedal International — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Device sterilization/disinfection container, reusable.
- SM - LIPO PANTY CHEVILLES COUPE TAILLE NOIR AVEC TROUS RECOUVERTS SUR MESURE — MEDICAL Z · Class I
- APTUS — Medartis Inc. · Class I
- APTUS — Medartis Inc. · Class II
- INSTRUMENTS TRAYS WITHOUT LID, 200x100x25MM — DAUD JEE MFG. CO · Class I
- Breastform Cover Right Size 03 (478/ 482) — Trulife · Class I
- NCB® Periprosthetic Plate System — Zimmer, Inc. · Class I
- NTOC cassette — NTOC medische techniek B.V · Class I
- MIRABOR-CA (12 BURS)- — Hager Worldwide, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5430000258FlexGRIPNSC9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bedal International
- EUDAMED SRN
- BE-MF-000001242
Sources (2)
- EUDAMED a8aa9236-a788-4012-a3e7-e0830fdc70be 61 fields · synced Jul 10, 2026
- FDA UDI 27211707-3206-4feb-87fe-c1ef8b04d3cb 37 fields · synced May 30, 2026