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Disposable Nebulizer Mask

by Ningbo Runmai Medical Technology Co., Ltd.

Ref RME01Model CE003

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697237383NEBTD Basic UDI-DI 06972373830154UDI-DIDate21 Oct 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  • Withdrawn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
CE003, RME01
Primary DI / UDI-DI
06972373830154
Basic UDI-DI
697237383NEBTD
EMDN Code
R03010304 Aerosol therapy kits
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000039459
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

From the manufacturer

Manufacturer's product page: Nebulizer Mask

Other devices from Ningbo Runmai Medical Technology Co., Ltd.

See all devices from Ningbo Runmai Medical Technology Co., Ltd. →

Properties

  • Administering Medicine

Other properties (12)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No