FlexGRIP EPI/PNB 20-16G
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- FlexGRIP EPI/PNB 20-16G 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 EUDAMEDSterile, single use patches for stabilization of catheters, tubing, and cables EUDAMEDSterilized FDA UDI
- Model / Reference
- FlexGRIP EUDAMEDEP02-NS EUDAMEDEP02-B EUDAMEDEP02 EUDAMEDbedal flex, epi/pnb FDA UDI
- Description
- Sterilized FDA UDI
Identifiers
- Catalog Number
- EP02 FDA UDI
- Primary DI / UDI-DI
- 05430004283201 EUDAMED05430004283805 EUDAMED05430000258364 EUDAMEDFDA UDI
- Basic UDI-DI
- 5430000258FlexGRIPNSC9 EUDAMED5430000258FlexGRIPSAF 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 — 95 Millimeter FDA UDIWidth — 60 Millimeter FDA UDIHeight — 6.4 Millimeter FDA UDI
Category: Device sterilization/disinfection container, reusable
FlexGRIP EPI/PNB 20-16G 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 | 5430000258FlexGRIPNSC9 | 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 (4)
- EUDAMED 93a82219-9cbf-495d-996d-0896a348b180 61 fields · synced Aug 1, 2026
- EUDAMED d7e563f5-c5e8-4e77-a534-e56645dad3c7 61 fields · synced May 18, 2026
- EUDAMED 29698bb4-5114-4f59-a73a-6596ba573e9e 61 fields · synced May 18, 2026
- FDA UDI f2fd3182-ea49-441d-86ef-d24ee49e3348 37 fields · synced May 30, 2026