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Medical Ventilator

by Shenyang RMS Medical Tech Co., Ltd. China EUDAMED

Ref BPAP HE90Model BPAP-HD80

EMDN R0499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6957469402005DY Basic UDI-DIDate1 Jun 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Medical Ventilator
Model / Reference
BPAP-HD80, BPAP HE90
Primary DI / UDI-DI
06957469401760
Basic UDI-DI
6957469402005DY
EMDN Code
R0499 Respiratory filters - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000023286
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Shenyang RMS Medical Tech Co., Ltd.

See all devices from Shenyang RMS Medical Tech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 4a8e397a-3b9e-4883-aeef-ea94b396fb73 61 fields · synced 24 Oct 2026