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nMask, 30mm

by GaleMed Corporation Taiwan EUDAMED

Ref AN0039Model (O) Mask

EMDN R03010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471081008RNOMAP Basic UDI-DIDate7 May 2026RegisteredStatusActive

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
Reusable Silicone Mask
Model / Reference
(O) Mask, AN0039
Primary DI / UDI-DI
04710810104251
Basic UDI-DI
471081008RNOMAP
Direct Marketing DI
04710810104251
EMDN Code
R03010201 Air/oxygen masks
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
TW-MF-000022411
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from GaleMed Corporation

See all devices from GaleMed Corporation →

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 04710810104251|471081008RNOMAP 61 fields · synced 24 Oct 2026