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Leukoplast® 76458-12

by Bsn Medical, Inc.

Ref 71291-00, 71280-00, 71231-00, 71280-04, 71280-01, 71280-02, 76462-03, 76458-12

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number404280940049862AX Basic UDI-DI Date7 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042809702743 UDI-DI Date17 Apr 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Leukoplast®
Generic Name
Skin-cover adhesive strip, non-antimicrobial
Device Name
Leukoplast® wet wipe
Leukoplast® compress absorbent soft
Leukoplast® swab abdominal
Leukoplast® universal
Model / Ref / Catalog
76458-12, 71291-00, 71280-00, 71231-00, 71280-04, 71280-01, 71280-02, 76462-03
Primary DI / UDI-DI
04042809702743, 04042809804393, 04042809811599, 04042809795332, 04042809811636, 04042809811605, 04042809811612, 04042809661910
Basic UDI-DI
404280940049862AX, 404280940049821AH, 404280940048586AP, 4042809400343278N, 40428094004374198
Unit of Use DI
04042809811322, 04042809803266, 04042809795356, 04042809803341, 04042809803280, 04042809803303, 04042809661927
FDA Product Code
NAD
EMDN Code
M02030201, M040201, M0201020201, M04010199, M04010102
GMDN Term
Skin-cover adhesive strip, non-antimicrobial
Device Class
Class I EUDAMEDGUDID
Class IIa EUDAMED
Regulation Number
878.4020
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Width — 6 Centimeter
Length — 100 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
Class IIa
GUDID
Class I
SterileEUDAMED
No
Yes
GUDID
No

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Properties

  • Sterile NoEUDAMEDGUDIDYesEUDAMED
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Single Use: No
  • 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: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No