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Smartlux Mini D478000

by Medmix Co., Ltd.

Ref SMARTLUX MINI

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800077100045 Basic UDI-DI 08800077100045UDI-DIDate18 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800077100045 UDI-DI Date25 Jul 2022ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Smartlux Mini
Generic Name
Red-light phototherapy unit, professional
Device Name
Phototherapy Unit
Model / Reference
SMARTLUX MINI EUDAMED
D478000 GUDID
Primary DI / UDI-DI
08800077100045
Basic UDI-DI
B-08800077100045
510(k) Number
FDA Product Code
GEX, ILY
EMDN Code
Z12040202 Phototherapy equipment
GMDN Term
Red-light phototherapy unit, professional
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4810, 890.5500
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SMARTLUX MINI
GUDID
D478000
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Medmix Co., Ltd.

  • Smartlux Mini

    Class II

  • Smartlux

    Class II

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No