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Alpha

by Alpha Solway Ltd United Kingdom EUDAMED

Ref ASRHXC300AHModel HXCL-3 EMDN T020604

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5060855886HXCL386 Basic UDI-DIDate4 Dec 2023RegisteredStatusActive

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  • Withdrawn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 · synced 25 Oct 2026

Device Name
HXCL-3 Clear Panel Horizontal Fold Flat FFP3
Model / Reference
HXCL-3, ASRHXC300AH
Primary DI / UDI-DI
05060855886995
Basic UDI-DI
5060855886HXCL386
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-000019916
Authorised representative
Globus EMEA Ltd IE-AR-000002785

Other devices from Alpha Solway Ltd

See all devices from Alpha Solway Ltd →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 5bc3b6dc-e617-44d5-8f4b-2a048e4b280e 61 fields · synced 25 Oct 2026