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Isolation Gown Pppe 40 with Knitted Cuff

by Operating Theatre Medical (Zhijiang) Co., Ltd EUDAMED

Active European Union

Ref I001446OTM, I001440OTM, I001239OTM, I001105OTM, I001443OTM, I001437OTM, I001441OTM, I001438OTM, I001237OTM, I001240OTM, I001238OTM, I001444OTM, I001175OTM, I001235OTMModel Blue/green/yellow/white Isolation gown with elastic cuff or knitted cuff

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6976128075000B3 Basic UDI-DIDate19 Apr 2024RegisteredStatusActive

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  • Withdrawn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

Device Name
Isolation gown for single use
Model / Reference
Blue/green/yellow/white Isolation gown with elastic cuff or knitted cuff, I001446OTM, I001440OTM, I001239OTM, I001105OTM, I001443OTM, I001437OTM, I001441OTM, I001438OTM, I001237OTM, I001240OTM, I001238OTM, I001444OTM, I001175OTM, I001235OTM
Primary DI / UDI-DI
06976128075357, 06976128075418, 06976128075142, 06976128075050, 06976128075326, 06976128075388, 06976128075425, 06976128075395, 06976128075128, 06976128075159, 06976128075135, 06976128075333, 06976128075074, 06976128075104
Basic UDI-DI
6976128075000B3
Unit of Use DI
16976128075354, 16976128075415, 16976128075149, 16976128075057, 16976128075323, 16976128075385, 16976128075422, 16976128075392, 16976128075125, 16976128075156, 16976128075132, 16976128075330, 16976128075071, 16976128075101
EMDN Code
T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000038254
Authorised representative
mono-uso nv BE-AR-000001322

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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