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Dermatological Diode Laser Systems

by Zhuolu Jontelaser Manufacturing Technology Co.,Ltd. 2 variants

Ref /Model T8Pro

Active European Union

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 NumberB-06975568903022 Basic UDI-DI 06975568903022UDI-DIDate16 Apr 2024RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Model / Reference
T8Pro, /
Primary DI / UDI-DI
06975568903022
Basic UDI-DI
B-06975568903022
EMDN Code
Z120615 Therapeutic lasers
Device Class
Class IIb
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000017954
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Zhuolu Jontelaser Manufacturing Technology Co.,Ltd.

Properties

  • Reusable

Other properties (10)

  • Sterile: No
  • Implantable: 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