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Diode Laser Therapy System

by Beijing ADSS Development Co., Ltd 3 variants

Ref Diode Laser Therapy SystemModel FG2000-B,FG2000-B Pro,FG2000D+ 001,FG2000D+ 003,FG2000D+005,FG2000D+ 006,QRYO-101104,AlphaSheer Max

Active European Union

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697045327075FG2000D+001X9 Basic UDI-DI Date4 Sep 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference
FG2000-B, FG2000-B Pro, FG2000D+ 001, FG2000D+ 003, FG2000D+005, FG2000D+ 006, QRYO-101104, AlphaSheer Max, Diode Laser Therapy System
Primary DI / UDI-DI
06970453270791, 06970453270777, 06970453270784, 06970453270753, 06970453270760
Basic UDI-DI
697045327075FG2000D+001X9
Direct Marketing DI
06970453270791
06970453270777
06970453270784
06970453270753
06970453270760
EMDN Code
Z12011016 Diode surgical laser
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000013103
Authorised representative
Prolinx GmbH DE-AR-000005129

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See all devices from Beijing ADSS Development Co., Ltd. →

Properties

Other properties (13)

  • Sterile: 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