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Medical Intense Pulsed Light Treatment System
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref EROSE-YRef HM-IPL-B1Ref HM-IPL-B6
Identity
- Device Name
- Medical Intense Pulsed Light Treatment System EUDAMED
- Model / Reference
- EROSE-Y EUDAMEDHM-IPL-B1 EUDAMEDHM-IPL-B6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973512860070 EUDAMED06973512860087 EUDAMED06973512860094 EUDAMED
- Basic UDI-DI
- B-06973512860070 EUDAMEDB-06973512860087 EUDAMEDB-06973512860094 EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Category: Red-light phototherapy unit, professional
Medical Intense Pulsed Light Treatment System by Shandong Huamei Technology Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K192521 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K230816 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06973512860070 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shandong Huamei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025482
- Authorised Representative
- Tech4beauty GmbH DE-AR-000024345
Sources (4)
- EUDAMED 1bad298b-72b0-4b7c-88e0-2bc9f3489f2b 61 fields · synced Sep 18, 2026
- EUDAMED da2f920e-8a59-4e9e-b722-339ab4a8fad0 61 fields · synced May 17, 2026
- EUDAMED aafd3bd9-769b-4833-b46b-cc283be3a101 61 fields · synced May 19, 2026
- FDA 510(k) K192521 1 fields · synced May 18, 2026