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FlexGRIP Universal 5-11 Fr

by Bedal International Belgium EUDAMEDGUDID

Ref UN511-CAPModel FlexGRIP

Product code KMKEMDN V9099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05430000258005 UDI-DIDate30 Apr 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED NumberBE24/00000301 Date27 Nov 2024IssuedStatusActive expires 27 Nov 2029

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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • 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 Universal 5-11 Fr EUDAMED
FlexGRIP 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, UN511-CAP, FlexGRIP Universal 5-11 Fr
Primary DI / UDI-DI
05430000258005
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
FlexGRIP
UN511-CAP
GUDID
FlexGRIP Universal 5-11 Fr

Manufacturer details

EUDAMED SRN
BE-MF-000001242

From the manufacturer

Manufacturer's product page: Universal

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
Other properties (18)
  • 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
  • Manufacturing Date: No

Sources (2)

  • EUDAMED ca938ad2-3ff9-4dbd-b630-ea52680f38d8 61 fields · synced 22 Oct 2026
  • FDA UDI 719676a6-a55b-4563-b112-a87dd0585d48 35 fields · synced 22 Oct 2026