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Diode Laser Therapy Systems

by BEIJING UNT Technology Co., Ltd.

Ref Alpha

Diode Laser Therapy Systems (Alpha) is a dermatological diode laser system (EU MDR Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Beijing Unt Technology Co., Ltd, registered in EUDAMED on 21 Mar 2024 (Basic UDI-DI 697366379104P9) with CE/MDR certificate CN24/00001171 valid until 26 Feb 2029, cleared under FDA 510(k) K212978 on 10 Nov 2021 and listed in FDA GUDID since 25 Apr 2024 (UDI-DI 06973663791049), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

26 Feb 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier SGS Belgium NV

510(k) K212978↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06973663791049 UDI-DI Date25 Apr 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697366379104P9 Basic UDI-DI 06973663791049UDI-DIDate21 Mar 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK212978 Date10 Nov 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697366379104P9 registered 21 Mar 2024 Active· +1 more in the status table
  • FDA 510(k) K212978 decided 10 Nov 2021 Active
  • FDA GUDID UDI-DI 06973663791049 listed 25 Apr 2024 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN24/00001171 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    26 Feb 2024
    Expires
    26 Feb 2029

Timeline

5 dated events

  1. Cleared FDA 510(k) K212978
  2. Certificate issued EUDAMED CN24/00001171
  3. Registered EUDAMED 697366379104P9
  4. Listed FDA GUDID 06973663791049
  5. Certificate expires EUDAMED CN24/00001171

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Dermatological diode laser system
Model / reference
Alpha
Primary DI / UDI-DI
06973663791049
Basic UDI-DI
697366379104P9
Direct marketing DI
06973663791049
510(k) Number
FDA product code
GEX
EMDN code
Z12011016 Diode surgical laser
GMDN term
Dermatological diode laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CN-MF-000019748
Authorised representative
MedPath GmbH DE-AR-000000087

Similar devices in this category

Other devices filed under DIODE SURGICAL LASER.

Other devices from Beijing Unt Technology Co., Ltd

Properties

  • Serial number
Other properties (24, all answered No)