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Zx-N77A02-OS01BA-B00

by Leboo Healthcare Products Limited

Ref ZX-N77A02-OS01BA-B00Model Surgical Face Mask (IIR With Tie-On、Surgical Face Mask (IIR With Earloop、Surgical Face Mask (IIR Children

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697442484L25QM Basic UDI-DI 06974424841010UDI-DIDate16 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Surgical Face Mask (IIR With Tie-On、Surgical Face Mask (IIR With Earloop、Surgical Face Mask (IIR Children, ZX-N77A02-OS01BA-B00
Primary DI / UDI-DI
06974424841010
Basic UDI-DI
697442484L25QM
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000008521
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Leboo Healthcare Products Limited

See all devices from Leboo Healthcare Products Limited →

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