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Zogear

by ZOGEAR Medical Co., Ltd. 64 variants

Ref PB012-4Model PB012-1,PB012-2,PB012-3,PB012-4,PB012-5,PB012-6,PB012-7,PB012-8

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697484312PB012G3 Basic UDI-DI 06974843122967UDI-DIDate5 Nov 2026RegisteredStatusActive

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  • Withdrawn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
Bouffant cap
Model / Reference
PB012-1, PB012-2, PB012-3, PB012-4, PB012-5, PB012-6, PB012-7, PB012-8
Primary DI / UDI-DI
06974843122967
Basic UDI-DI
697484312PB012G3
EMDN Code
T0207 Caps and headwear (excluding personal protective equipment - PPE)
Device Class
Class I
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000012353
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from ZOGEAR Medical Co., Ltd.

See all devices from ZOGEAR Medical 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