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Zhuobo

by Xiantao Zhuobo Industrial Co., LTD 2 variants

Ref Flat type (175mm*95mm), 15X36CM, S/Model Flat type (175mm*95mm), Hanging ear type (175mm*95mm), 15X36CM 15X41CM 15X45CM, S/ M/ L/

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 Number697338469xtzb011PY Basic UDI-DI Date11 Aug 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  • Withdrawn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
Medical Mask
Shoe cover
Disposable Cap
Model / Reference
Flat type (175mm*95mm), Hanging ear type (175mm*95mm), 15X36CM 15X41CM 15X45CM, 15X36CM, S/ M/ L/, S/
Primary DI / UDI-DI
06973384690119, 06973384697118, 06973384696111
Basic UDI-DI
697338469xtzb011PY, 697338469xtzb711R3, 697338469xtzb611QW
EMDN Code
T020604, T0208, T0207
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000036866
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Xiantao Zhuobo Industrial 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