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Intragastric Balloon System

by Changzhou Panda Medical Co., Ltd.

Ref PA450

Active European Union

CE MDR

Valid until

14 May 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697529350C01PQ Basic UDI-DI 06975293500077UDI-DIDate20 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 810929 Active

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    15 May 2026
    Expires
    14 May 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
PA450
Primary DI / UDI-DI
06975293500077
Basic UDI-DI
697529350C01PQ
EMDN Code
G030601 Intragastric balloon systems
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000042944
Authorised representative
MedPath GmbH DE-AR-000000087

Properties

  • Implantable

Other properties (13)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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