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Ventilation Mask

by GuangDong EDA Technology Co., Ltd. 52 variants

Ref FM-003-TM, NM-002-TMModel Ultrasonic Welding Ventilation Mask Series, Non-Ultrasonic Welding Ventilation Mask Series

Active European Union

CE MDR CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06974832560411 Basic UDI-DI Date15 Jan 2025RegisteredStatusActive
European UnionCE/MDD NumberB-06974832560411 Basic UDI-DI Date15 Jan 2025RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Model / Reference
FM-003-TM, NM-002-TM, Ultrasonic Welding Ventilation Mask Series, Non-Ultrasonic Welding Ventilation Mask Series
Primary DI / UDI-DI
06974832560411, 06974832560404
Basic UDI-DI
B-06974832560411, B-06974832560404, 697483256FNMV6, 697483256YM6D
EMDN Code
R0301010201, R0301010202
Device Class
Class IIa
Market of Registration
Netherlands
Italy
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000008460
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from GuangDong EDA Technology Co., Ltd.

See all devices from GuangDong EDA Technology Co., Ltd. →

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