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Isolation gowns

by CDM Center of Excellence Ltd. EUDAMED

Active European Union

Ref 3145873

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697180887bjdl0525017XX Basic UDI-DIDate29 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
3145873
Primary DI / UDI-DI
06971808877009
Basic UDI-DI
697180887bjdl0525017XX
Unit of Use DI
86971808877005
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000013454
Authorised representative
Wellkang Ltd XI-AR-000001836

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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