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Ulike UI04S BU

by Shenzhen Ulike Smart Electronics Co., Ltd.

Ref UI04S BUModel UI04B, UI20 Series, UI20S Series, UI04S Series, UI06S Series, MI01 Series

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697466782IPLYC Basic UDI-DI 06974667824580UDI-DIDate5 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06974667824580 UDI-DI Date9 Jun 2025ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ulike
Generic Name
Home-use intense pulsed light hair removal unit
Device Name
Ice Cooling IPL Hair Removal Device
Model / Reference
UI04S BU, UI04B, UI20 Series, UI20S Series, UI04S Series, UI06S Series, MI01 Series
Primary DI / UDI-DI
06974667824580 EUDAMED
06974667826126 GUDID
Basic UDI-DI
697466782IPLYC
Direct Marketing DI
06974667824580
FDA Product Code
OHT
EMDN Code
X0502 High intensity electromagnetic radiation emitting equipment without an intended medical purpose intended for use on the human body, for skin resurfacing, tattoo or hair removal or other skin treatment – intense pulsed light
GMDN Term
Home-use intense pulsed light hair removal unit
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06974667824580
GUDID
06974667826126
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Shenzhen Ulike Smart Electronics Co., Ltd

See all devices from Shenzhen Ulike Smart Electronics Co., Ltd →

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No