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Isolationgown

by Xiantao WellMed Protective Products Co., Ltd. 3 variants

Model 22N031

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 Number697443937Isolationgown1CJ Basic UDI-DI 69744393700019UDI-DIDate2 Mar 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  • Withdrawn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
Isolationgown
Model / Reference
22N031
Primary DI / UDI-DI
69744393700019
Basic UDI-DI
697443937Isolationgown1CJ
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
EU market of registration
Cyprus

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