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FlexGRIP Neo. PICC

by Bedal International Belgium EUDAMEDGUDID

Ref PICCNEO-BModel FlexGRIP

Product code KMKEMDN V9099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05430004283928 UDI-DIDate19 Dec 2025ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number5430000258FlexGRIPSAF Basic UDI-DIDate6 Jan 2025RegisteredStatusActive

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 25 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 25 Oct 2026

Trade Name
FlexGRIP Neo. PICC 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, PICCNEO-B, FlexGRIP Neo. PICC
Primary DI / UDI-DI
05430004283928
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
PICCNEO-B
GUDID
FlexGRIP Neo. PICC

Manufacturer details

EUDAMED SRN
BE-MF-000001242

From the manufacturer

Manufacturer's product page: Neo.PICC

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 dd351d89-8341-4eda-aef5-6abf6d80ba8b 61 fields · synced 25 Oct 2026
  • FDA UDI afa0b8f9-96e4-460b-8595-341e4e277e7f 36 fields · synced 22 Oct 2026