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FlexGRIP EPI/PNB 20-16G

by Bedal International Belgium EUDAMEDGUDID

Ref EP02Model FlexGRIP Product code KMKEMDN V9099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5430000258FlexGRIPSAF Basic UDI-DIDate6 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05430000258364 UDI-DIDate31 Mar 2022ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • BE24/00000301 Issued

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    27 Nov 2024
    Expires
    27 Nov 2029

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
FlexGRIP EPI/PNB 20-16G EUDAMED
Bedal GUDID
Generic Name
Synthetic polymer semi-permeable film dressing, adhesive
Device Name
Sterile, single use patches for stabilization of catheters, tubing, and cables
Model / Ref / Catalog
FlexGRIP, EP02, FlexGRIP EPI/PNB 20-16G
Primary DI / UDI-DI
05430000258364
Basic UDI-DI
5430000258FlexGRIPSAF
FDA Product Code
KMK
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Synthetic polymer semi-permeable film dressing, adhesive
Device Class
Class I
Regulation Number
880.5210
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 95 Millimeter
Width — 60 Millimeter
Height — 6.4 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
FlexGRIP
EP02
GUDID
FlexGRIP EPI/PNB 20-16G

Manufacturer details

EUDAMED SRN
BE-MF-000001242

From the manufacturer

Manufacturer's product page: EPI/PNB

Related devices

Category: Device sterilization/disinfection container, reusable

Other devices from Bedal International

See all devices from Bedal International →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (17)
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No

Sources (2)

  • EUDAMED 29698bb4-5114-4f59-a73a-6596ba573e9e 61 fields · synced 22 Oct 2026
  • FDA UDI f2fd3182-ea49-441d-86ef-d24ee49e3348 37 fields · synced 30 May 2026