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Disposable Isolation Gown

by Hubei Zhencheng Non Woven Products Co., Ltd 2 variants

Ref Regular style/blue/25gsm/115*137cmModel Regular style/blue/25gsm/110*135cm Regular style/blue/25gsm/115*137cm Regular style/blue/25gsm/120*140cm Regular style/blue/25gsm/160*125cm

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 Number697518075IG01KA Basic UDI-DI 06975180751025UDI-DIDate22 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  • Withdrawn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
Disposable Isolation Gown
Model / Reference
Regular style/blue/25gsm/110*135cm Regular style/blue/25gsm/115*137cm Regular style/blue/25gsm/120*140cm Regular style/blue/25gsm/160*125cm, Regular style/blue/25gsm/115*137cm
Primary DI / UDI-DI
06975180751025
Basic UDI-DI
697518075IG01KA
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000008257
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hubei Zhencheng Non Woven Products Co., Ltd

See all devices from Hubei Zhencheng Non Woven 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