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Diode Laser Therapy System
EUDAMEDClass IIa (EU MDR)
Ref Diode Laser Therapy SystemModel FG2000-B,FG2000-B Pro,FG2000D+ 001,FG2000D+ 003,FG2000D+005,FG2000D+ 006,QRYO-101104,AlphaSheer Max
Identity
- Trade Name
- Diode Laser Therapy System EUDAMED
- Device Name
- Diode Laser Therapy System EUDAMED
- Model / Reference
- FG2000-B,FG2000-B Pro,FG2000D+ 001,FG2000D+ 003,FG2000D+005,FG2000D+ 006,QRYO-101104,AlphaSheer Max EUDAMEDDiode Laser Therapy System EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970453270807 EUDAMED
- Basic UDI-DI
- 697045327075FG2000D+001X9 EUDAMED
- Direct Marketing DI
- 06970453270807 EUDAMED
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Diode Laser Therapy System by Beijing ADSS Development Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697045327075FG2000D+001X9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing ADSS Development Co., Ltd
- EUDAMED SRN
- CN-MF-000013103
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 4ca6a85f-c09e-4c6c-8540-a3b5821def53 61 fields · synced Jun 18, 2026