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Intensity Pulsed Light Therapy System
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Intensity Pulsed Light Therapy SystemModel VE2000, VE2000 Pro, VE2000 Pro001, VE2000 Pro002, VE2000 Pro003
Identity
- Trade Name
- Intensity Pulsed Light Therapy System EUDAMED
- Device Name
- Intensity Pulsed Light Therapy System EUDAMED
- Model / Reference
- VE2000, VE2000 Pro, VE2000 Pro001, VE2000 Pro002, VE2000 Pro003 EUDAMEDIntensity Pulsed Light Therapy System EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970453270999 EUDAMED06970453270845 EUDAMED06970453270982 EUDAMED06970453271002 EUDAMED
- Basic UDI-DI
- 697045327VE2000BJ EUDAMED
- Direct Marketing DI
- 06970453270999 EUDAMED06970453270845 EUDAMED06970453270982 EUDAMED06970453271002 EUDAMED
- EMDN Code
- Z12011019 MULTI–PLATFORM 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
Intensity Pulsed Light Therapy System by Beijing ADSS Development Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233307 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697045327VE2000BJ | 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 (5)
- EUDAMED 38e805b1-a169-43d2-85e8-bb0741df7a80 61 fields · synced Jul 29, 2026
- EUDAMED ce52384e-5848-45b4-8253-9b95d52607f7 61 fields · synced May 18, 2026
- EUDAMED 96785f0f-c725-45f8-b5fe-ff69bf522c40 61 fields · synced May 19, 2026
- EUDAMED 8be272d4-d981-4c64-8d58-c1ba472b0163 61 fields · synced May 19, 2026
- FDA 510(k) K233307 1 fields · synced May 18, 2026