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Reusable Headgear

by GaleMed (Xiamen) Co., Ltd. 2 variants

Ref AM0015

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69239801NR1EARP Basic UDI-DI 16923980102612UDI-DIDate6 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Reusable Headgear
Model / Reference
AM0015
Primary DI / UDI-DI
16923980102612
Basic UDI-DI
69239801NR1EARP
EMDN Code
R03010180 Artificial ventilation masks - accessories
Device Class
Class I
EU market of registration
Belgium

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

  • 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