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Isolation gown

by Xiantao Fortune Medical Supplies Co., Ltd. 3 variants

Ref 2169721

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 Number697439066fy-1016C Basic UDI-DIDate31 Mar 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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

Model / Reference
2169721
Primary DI / UDI-DI
06974390660349, 06974390660332, 06974390660356, 06974390660004
Basic UDI-DI
697439066fy-1016C
EMDN Code
T0203 Dressing and assistance kits
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000003236
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xiantao Fortune Medical Supplies Co., Ltd.

See all devices from Xiantao Fortune Medical Supplies 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