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Dermatological Diode Laser Systems
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref CM02D510(k) K210663
Identity
- Trade Name
- Dermatological Diode Laser Systems EUDAMED
- Device Name
- Dermatological Diode Laser Systems EUDAMED
- Model / Reference
- CM02D EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CM02DT4 EUDAMED
- Basic UDI-DI
- B-CM02DT4 EUDAMED
- EMDN Code
- Z12040201 PHOTOEPILATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Dermatological Diode Laser Systems by Beijing HuaCheng Taike Technology Co., Ltd. — Class IIa — 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 | K210663 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-CM02DT4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing HuaCheng Taike Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000041607
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 8170136c-1036-440c-a827-fdccd684b251 85 fields · synced Jun 18, 2026
- FDA 510(k) K210663 1 fields · synced May 18, 2026