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Plum QuickFix XRay

by Plum Safety ApS

Ref 5524Model Plaster

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05715205000438 UDI-DI Date17 Feb 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5715205QFPLASTER01SS Basic UDI-DI 05715205000438UDI-DIDate22 Jun 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Plum QuickFix XRay EUDAMED
Plum QuickFix GUDID
Generic Name
Skin-cover adhesive strip, non-antimicrobial
Model / Ref / Catalog
Plaster, 5524, XRay
Primary DI / UDI-DI
05715205000438
Basic UDI-DI
5715205QFPLASTER01SS
FDA Product Code
KGX
EMDN Code
M04010199 Adhesive dressings, with absorbent pad - other
GMDN Term
Skin-cover adhesive strip, non-antimicrobial
Device Class
Class I
Regulation Number
880.5240
Market of Registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Plaster
5524
GUDID
XRay
Contains LatexEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
DK-MF-000008672

Other devices from Plum Safety ApS

See all devices from Plum Safety ApS →

Properties

  • Single Use
  • Contains Latex NoEUDAMEDYesGUDID
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: 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: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No