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Laica(Kuwait)

by Foshan Gaunying Electronics Co., Ltd.

Part of a family of 9 devices: see the family page

Ref NE1005Model IH55

Laica(Kuwait) (NE1005) is a Class IIa device made by Foshan Gaunying Electronics Co., Ltd., registered in EUDAMED on 10 Oct 2023 (Basic UDI-DI 697538356N01ST), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697538356N01ST Basic UDI-DI 06975383560066UDI-DIDate10 Oct 2023RegisteredStatusActive EUDAMED: not on the EU market

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Nebulizer
Model / reference
IH55, NE1005
Primary DI / UDI-DI
06975383560066
Basic UDI-DI
697538356N01ST
EMDN code
R060101 Cold nebulisation systems
Device class
Class IIa
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device

Manufacturer details

EUDAMED SRN
CN-MF-000017213
Authorised representative
Wellkang Ltd XI-AR-000001836

Similar devices in this category

Other devices filed under COLD NEBULISATION SYSTEMS.

Other devices from Foshan Gaunying Electronics Co., Ltd.

See all devices from Foshan Gaunying Electronics Co., Ltd. →

Properties

  • Administering medicine
Other properties (13, all answered No)