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Febelcare

by Nanhai Foshan City Fenghua Medical Appliance Co., Ltd. 3 variants

Ref WKE42501-1/ 4344-032, Medical Nebulizer KitsModel For mouth and child mask, For mouth and child mask (Product code: WKE42501-1), For mouth and mask (Product code: P115-1)

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number697339684WWKEXX Basic UDI-DI Date16 Jan 2026RegisteredStatusActive
European UnionCE/MDR Number697339684WWKEXX Basic UDI-DI Date16 Jan 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  • Withdrawn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/MDD, CE/MDR Active

Specification

EUDAMED

Trade Name
Febelcare
For mouth and child mask
SilMed Zestaw akcesoriów do inhalatora tłokowego ITF-01
Device Name
Medical Nebulizer Kits
Model / Reference
For mouth and child mask, WKE42501-1/ 4344-032, For mouth and child mask (Product code: WKE42501-1), Medical Nebulizer Kits, For mouth and mask (Product code: P115-1)
Primary DI / UDI-DI
06973396840205, 06973396840212
Basic UDI-DI
697339684WWKEXX, B-06973396840205, B-06973396840212
Direct Marketing DI
06973396840205
EMDN Code
R03010304 Aerosol therapy kits
Device Class
Class IIa
EU market of registration
France
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000002306
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Nanhai Foshan City Fenghua Medical Appliance Co., Ltd.

Properties

  • Reprocessed YesEUDAMEDNoEUDAMED
  • Administering Medicine

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No