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Disposable medical face mask(FFP 2 NR D)

by Hubei Yazhi Hygiene Products Co., Ltd 11 variants

Model YZ001, 15.5*10.5cm, can be customized, YZ001,15.5*10.5cm,can be customizedRef YZ001

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697480258MASK004VK Basic UDI-DI Date19 Apr 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Disposable medical face mask(FFP 2 NR D)
Disposable Medical Filtering Half Mask Type IIR
Model / Reference
YZ001, 15.5*10.5cm, can be customized, YZ001,15.5*10.5cm
Primary DI / UDI-DI
26974805280524, 16974805280527, 06974805280797
Basic UDI-DI
697480258MASK004VK, 697480528MASK004W5
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Germany
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000010782
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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