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CPAP face mask

by Da Chung Medical Co., Ltd. Taiwan EUDAMED

Ref 1601

EMDN R0301010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number47198732910VK Basic UDI-DIDate5 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
CPAP face mask
Model / Reference
1601
Primary DI / UDI-DI
04719873291663
Basic UDI-DI
47198732910VK
Direct Marketing DI
04719873291663
EMDN Code
R0301010201 Cpap masks
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
TW-MF-000037960
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Da Chung Medical Co., Ltd.

See all devices from Da Chung Medical 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 f21df004-c48a-4cef-b3ad-5eb71fef44e0 61 fields · synced 22 Oct 2026