← Back to catalogue
Medical Diode Laser Systems
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref F01-10FJModel BERYLAS-10FJ
Identity
- Device Name
- Medical Diode Laser Systems EUDAMED
- Model / Reference
- BERYLAS-10FJ EUDAMEDF01-10FJ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974214160253 EUDAMED
- Basic UDI-DI
- B-06974214160253 EUDAMED
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medical Diode Laser Systems by Wuhan DIMED LASER TECHNOLOGY CO., LTD. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211977 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06974214160253 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan Dimed Laser Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012344
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED b1d2111a-1d3a-4494-b32b-a5e21f6bb4ec 61 fields · synced Aug 4, 2026
- FDA 510(k) K211977 1 fields · synced May 18, 2026