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Medical Face Mask

by Henan Tuoren Medical Healthcare Products Co., Ltd. EUDAMED

Active European Union

Ref FMS1E10Model Type:Ear loop, Tie band Classification: Type l, Type ll, Type ll R. Size: 17.5cm×9.5cm, 14.5cm×9.5cm

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697286820072NF Basic UDI-DIDate5 Jun 2026RegisteredStatusActive

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  • Withdrawn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
Medical Face Mask
Model / Reference
Type:Ear loop, Tie band Classification: Type l, Type ll, Type ll R. Size: 17.5cm×9.5cm, 14.5cm×9.5cm, FMS1E10
Primary DI / UDI-DI
16972868201251
Basic UDI-DI
697286820072NF
EMDN Code
T020603 Medical use face masks, type i (not for healthcare professionals)
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000027709
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Henan Tuoren Medical Healthcare Products Co., Ltd.

See all devices from Henan Tuoren Medical Healthcare Products Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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