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Bandage

by Wellmien Healthcare Tech. (Suzhou) Co., Ltd. China EUDAMED

Ref 7.5X450CM, 15cmx460cmModel 5X450CM, 7.5X450CM, 15X270CM (As customized)

EMDN M03050201,M03050299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697457045B001EG Basic UDI-DIDate17 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
5X450CM, 7.5X450CM, 15X270CM (As customized), 15cmx460cm
Primary DI / UDI-DI
06974570451026, 06974570451002
Basic UDI-DI
697457045B001EG
EMDN Code
M03050201,M03050299
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000010365
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wellmien Healthcare Tech. (Suzhou) Co., Ltd.

See all devices from Wellmien Healthcare Tech. (Suzhou) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED 31dfa0ab-eea0-4e07-ab54-d2adac4f7725 61 fields · synced 22 Oct 2026
  • EUDAMED 06974570451002|697457045B001EG 61 fields · synced 18 May 2026