Skip to content

Top Mask

by Top Feel Sdn. Bhd. EUDAMED

Active European Union

Ref TM-598723040, TM-598723070

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955598720000NU Basic UDI-DIDate18 Jan 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Medical Face Mask
Model / Reference
TM-598723040, TM-598723070
Primary DI / UDI-DI
09555987230410, 09555987230106
Basic UDI-DI
955598720000NU
Direct Marketing DI
09555987230410
09555987230106
EMDN Code
T020604 Medical use face masks, type ii and iir
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
MY-MF-000018451
Authorised representative
Top Glove Europe GmbH DE-AR-000004968

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