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Face mask

by Wuhan Topmed Trading Co., Ltd. China EUDAMED

Ref M1005

EMDN T020604

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697047515FACEMASKYX Basic UDI-DIDate12 May 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Face mask
Prima Face Mask
Device Name
Nonwoven face mask
Model / Reference
M1005
Primary DI / UDI-DI
16970475157596, 16970475150139, 16970475150016
Basic UDI-DI
697047515FACEMASKYX
EMDN Code
T020604 Medical use face masks, type ii and iir
Device Class
Class I
Market of Registration
France
Romania
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000018876
Authorised representative
Caretechion GmbH DE-AR-000005946

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 (3)

  • EUDAMED f78cd78a-266a-4186-a382-c19203e2769f 61 fields · synced 22 Oct 2026
  • EUDAMED 19dc136b-970e-45bc-9e97-c9bec3792209 61 fields · synced 17 May 2026
  • EUDAMED 3a6b3f84-65cc-4b4e-b549-d1d722f8ede1 61 fields · synced 19 May 2026