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Non-sterile Adhesive Dressings

by Steroplast Healthcare Ltd 29 variants

Ref 6401L/12

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5020581STE010JM Basic UDI-DI 05020581261695UDI-DIDate19 Jun 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Non-sterile Adhesive Dressings
Model / Reference
6401L/12
Primary DI / UDI-DI
05020581261695
Basic UDI-DI
5020581STE010JM
EMDN Code
M040499 Dressings for wounds, sores and ulcerations - other
Device Class
Class I
EU market of registration
Malta

Manufacturer details

EUDAMED SRN
GB-MF-000018088
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Steroplast Healthcare Ltd

See all devices from Steroplast Healthcare Ltd →

Properties

  • Contains Latex

Other properties (12)

  • 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