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Nimo Disposable Pediatric Medical Face Mask

by Hünkar Ecza ve Medikal San. ve Tic. Ltd. Şti.

Ref HNK-MASK-CBModel HNK-MASK-CB, HNK-MASK-CD, HNK-MASK-YB, HNK-MASK-CF, HNK-MASK-YS

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number869897376HNK-MASKTH Basic UDI-DI 08698973761923UDI-DIDate12 May 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  • Withdrawn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
Disposable Surgical Face Mask
Model / Reference
HNK-MASK-CB, HNK-MASK-CD, HNK-MASK-YB, HNK-MASK-CF, HNK-MASK-YS
Primary DI / UDI-DI
08698973761923
Basic UDI-DI
869897376HNK-MASKTH
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000034965

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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