Skip to content

Non-sterile First Aid Dressings

by Steroplast Healthcare Ltd 63 variants

Ref 1613LF

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5020581STE011JP Basic UDI-DI 05020581285387UDI-DIDate20 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  • Withdrawn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 First Aid Dressings
Model / Reference
1613LF
Primary DI / UDI-DI
05020581285387
Basic UDI-DI
5020581STE011JP
Unit of Use DI
05020581285370
EMDN Code
M030402020101 Elastic support bandages, cohesive, extensible in one direction, high extensibility
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

Other properties (13)

  • 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