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Prima Face Mask

by Wuhan Topmed Trading Co., Ltd. EUDAMED

Active European Union

Ref M1005

Regulatory status

as of 26 Oct 2026

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

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  • Withdrawn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
Nonwoven face mask
Model / Reference
M1005
Primary DI / UDI-DI
16970475150023, 16970475150122
Basic UDI-DI
697047515FACEMASKYX
EMDN Code
T020604 Medical use face masks, type ii and iir
Device Class
Class I
Market of Registration
France
Romania

Manufacturer details

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

Other devices from Wuhan Topmed Trading Co., Ltd.

See all devices from Wuhan Topmed Trading Co., Ltd. →

Properties

Show 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