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Haika

by Globus (Shetland) Ltd EUDAMED

Active European Union

Ref HAK8002Model MXIIR

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5060680496376XT Basic UDI-DIDate21 Jan 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Surgical Mask
Model / Reference
MXIIR, HAK8002
Primary DI / UDI-DI
05060680496376
Basic UDI-DI
5060680496376XT
EMDN Code
T020604 Medical use face masks, type ii and iir
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000007384
Authorised representative
Globus EMEA Ltd IE-AR-000002785

Other devices from Globus (Shetland) Ltd

See all devices from Globus (Shetland) Ltd →

Properties

Show 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