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Emdamed

by Xiantao Longwin Medical Products Ltd. 20 variants

Ref DN-03/EMD95024Model DN-03

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697508986LWGOWN001LQ Basic UDI-DI 16975089862126UDI-DIDate3 Apr 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  • Withdrawn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
Isolation gown
Model / Reference
DN-03, DN-03/EMD95024
Primary DI / UDI-DI
16975089862126
Basic UDI-DI
697508986LWGOWN001LQ
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000012856
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xiantao Longwin Medical Products Ltd.

See all devices from Xiantao Longwin Medical Products 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