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Medical Diode Laser Therapy Systems
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref MED-808
Identity
- Trade Name
- Medical Diode Laser Therapy Systems EUDAMED
- Model / Reference
- MED-808 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971513122043 EUDAMED
- Basic UDI-DI
- B-06971513122043 EUDAMED
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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 Therapy Systems by Beijing Kes Biology Technology Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
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 | K210168 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06971513122043 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Beijing KES Biology Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000002099
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 22f7c06f-145c-4972-8823-4f15462aff31 61 fields · synced Jul 25, 2026
- FDA 510(k) K210168 1 fields · synced May 18, 2026