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Sterile film wound dressing with pads

by Shaoxing Yibon Medical Co., Ltd. EUDAMED

Active European Union

Ref 6358101Model Is

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697237076YB1SD13SM Basic UDI-DIDate18 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

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

Specification

EUDAMED

Model / Reference
Is, 6358101
Primary DI / UDI-DI
06972370764209
Basic UDI-DI
697237076YB1SD13SM
EMDN Code
M04010102 Polyurethane (or other material) adhesive dressings, with absorbent pad
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
CN-MF-000003378
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • Sterile

Other properties (12)

  • 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