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BPAP System

by Resvent Medical Technology Co., Ltd. China EUDAMED

Ref RXiBreeze 25S plus Pro EMDN Z12030102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-RXiBreeze25SplusPro49 Basic UDI-DIDate15 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
RXiBreeze 25S plus Pro
Primary DI / UDI-DI
D-RXiBreeze25SplusPro49
Basic UDI-DI
B-RXiBreeze25SplusPro49
EMDN Code
Z12030102 Continuous positive pressure equipment
Device Class
Class IIa
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000012608
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Resvent Medical Technology Co., Ltd.

See all devices from Resvent Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED D-RXIBREEZE25SPLUSPRO49|B-RXIBREEZE25SPLUSPRO49 61 fields · synced 25 Oct 2026