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Keep

by 4N Health Oy Ltd Finland EUDAMED

Ref 400 EMDN T020604

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number64298300663KeepsafeQT Basic UDI-DIDate25 Nov 2021RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Keep Safe
Model / Reference
400
Primary DI / UDI-DI
06429830066316
Basic UDI-DI
64298300663KeepsafeQT
EMDN Code
T020604 Medical use face masks, type ii and iir
Device Class
Class I
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000004502

Other devices from 4N Health Oy Ltd

  • Keep

    Class I

  • Keep

    Class I

  • Keep

    Class I

  • Keep

    Class I

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 ac8ec7c0-7001-48be-a074-0e46c20645f1 61 fields · synced 22 Oct 2026