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Medical Face Mask

by Taiwan Comfort Champ Manufacturing Co., Ltd. EUDAMED

Active European Union

Ref CMDII-01, CMDIIR-01Model Type II, Type IIR

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471987207MFMASKN4 Basic UDI-DIDate5 Oct 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  • Withdrawn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
Type II, Type IIR, CMDII-01, CMDIIR-01
Primary DI / UDI-DI
04719872078883, 04719872078890
Basic UDI-DI
471987207MFMASKN4
EMDN Code
T020604 Medical use face masks, type ii and iir
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000037811
Authorised representative
Caretechion GmbH DE-AR-000005946

Other devices from Taiwan Comfort Champ Manufacturing Co., Ltd.

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