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Disposable surgical gown

by Hebei Kangning Medical Equipment Co., Ltd 2 variants

Ref L, M, XLModel S、M、L、XL

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69333845surgicalgown44 Basic UDI-DI Date21 Mar 2025RegisteredStatusActive

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  • Withdrawn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
Disposable surgical gown
Model / Reference
S、M、L、XL, L, M, XL
Primary DI / UDI-DI
06933384500153, 06933384500146, 06933384500160
Basic UDI-DI
69333845surgicalgown44
EMDN Code
T020401 Standard surgical gowns
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047002
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hebei Kangning Medical Equipment Co., Ltd

See all devices from Hebei Kangning Medical Equipment Co., 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