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Disposable surgical gown

by Xiantao WellMed Protective Products Co., Ltd. 6 variants

Ref 2XLModel M/L/XL/2XL/3XL/4XL or Customized

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697443937surgicalgown03FC Basic UDI-DI 06974439373148UDI-DIDate19 Dec 2023RegisteredStatusActive

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  • Withdrawn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
surgical gown
Model / Reference
M/L/XL/2XL/3XL/4XL or Customized, 2XL
Primary DI / UDI-DI
06974439373148
Basic UDI-DI
697443937surgicalgown03FC
EMDN Code
T020401 Standard surgical gowns
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000011448
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xiantao WellMed Protective Products Co., Ltd.

See all devices from Xiantao WellMed Protective Products 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