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SYNEK Medical Surgical Face Mask, type IIR, with earloops, white

by Alison Hayes (Romania) SRL

Ref AH-DM12-WHITE-E

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 Number59447569AHDM12ETMK0001EW3 Basic UDI-DI 05944756900571UDI-DIDate23 Dec 2021RegisteredStatusActive

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  • Withdrawn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
Medical Surgical Face Mask,Type IIR
Model / Reference
AH-DM12-WHITE-E
Primary DI / UDI-DI
05944756900571
Basic UDI-DI
59447569AHDM12ETMK0001EW3
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000004583

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Properties

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