Skip to content

Reusable Headgear

by GaleMed (Xiamen) Co., Ltd. China EUDAMED

Ref AM0037

EMDN R03010199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69239801NR1EARP Basic UDI-DIDate6 Feb 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 Headgear
Model / Reference
AM0037
Primary DI / UDI-DI
16923980102926
Basic UDI-DI
69239801NR1EARP
EMDN Code
R03010199 Ventilation masks - other
Device Class
Class I
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000020627
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from GaleMed (Xiamen) Co., Ltd.

See all devices from GaleMed (Xiamen) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reprocessed
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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 16923980102926|69239801NR1EARP 61 fields · synced 24 Oct 2026