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BPAP device

by Xiaoniu Health Co., Ltd. EUDAMED

Active European Union

Ref 112000315, 112000317, 112000318Model AS100A,AS100C,BF20A,BF25A,BF25ST,BF30ST

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697286069CPAPQU Basic UDI-DIDate17 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Continuous Positive Airway Pressure Units
Model / Reference
AS100A, AS100C, BF20A, BF25A, BF25ST, BF30ST, 112000315, 112000317, 112000318
Primary DI / UDI-DI
06972860691701, 06972860691725, 06972860691732
Basic UDI-DI
697286069CPAPQU
EMDN Code
Z12030102 Continuous positive pressure equipment
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000014716
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Xiaoniu Health 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