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Isolation gowns

by ZOGEAR Medical Co., Ltd. EUDAMED

Active European Union

Ref PB015-1、PB015-2、PB015-3、PB015-4、PB015-5、PB015-6、PB015-7、PB015-8、PB015-9、PB015-10、PB015-11、PB015-12Model PB015-1, PB015-2，PB015-3, PB015-4, PB015-5, PB015-6, PB015-7, PB015-8, PB015-9, PB015-10, PB015-11, PB015-12

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697484312PB015G9 Basic UDI-DIDate10 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
PB015-1, PB015-2，PB015-3, PB015-4, PB015-5, PB015-6, PB015-7, PB015-8, PB015-9, PB015-10, PB015-11, PB015-12, PB015-1、PB015-2、PB015-3、PB015-4、PB015-5、PB015-6、PB015-7、PB015-8、PB015-9、PB015-10、PB015-11、PB015-12
Primary DI / UDI-DI
06974843121588
Basic UDI-DI
697484312PB015G9
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
Market of Registration
Germany

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