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Pflastersortiment, DIN 13019

by Hans Hepp GmbH & Co. KG

Ref 91485

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04007418914857 UDI-DI Date25 Jul 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4007418PflasterGC Basic UDI-DI 04007418914857UDI-DIDate14 Jun 2022RegisteredStatusActive

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  • Withdrawn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
Pflastersortiment, DIN 13019 EUDAMED
Plaster Assortment GUDID
Generic Name
Skin-cover adhesive strip, non-antimicrobial
Device Name
Pflaster
Model / Reference
91485
Primary DI / UDI-DI
04007418914857
Basic UDI-DI
4007418PflasterGC
FDA Product Code
KGX
EMDN Code
M04010101, M04010102
GMDN Term
Skin-cover adhesive strip, non-antimicrobial
Device Class
Class I
Regulation Number
880.5240
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
DE-MF-000006024

Other devices from Hans Hepp GmbH & Co. KG

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Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: 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
  • Expiration Date: No