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Medical Intense Pulsed Light Treatment System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref EROSE-YA
Identity
- Trade Name
- Huamei FDA UDI
- Generic Name
- Intense pulsed light skin surface treatment system FDA UDI
- Device Name
- Medical Intense Pulsed Light Treatment System EUDAMED
- Model / Reference
- EROSE-YA EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973512860056 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06973512860056 EUDAMED
- 510(k) Number
- K230816 FDA UDI
- FDA Product Code
- ONF FDA UDI
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Intense pulsed light skin surface treatment system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Medical Intense Pulsed Light Treatment System by Shandong Huamei Technology Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973512860056 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Shandong Huamei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025482
- Authorised Representative
- Tech4beauty GmbH DE-AR-000024345
Sources (2)
- EUDAMED c7f34380-9812-43dc-855c-e6690e85fc03 61 fields · synced Jul 22, 2026
- FDA UDI 462f9b54-1ea3-45d4-8d1f-7fd3565632ec 33 fields · synced May 30, 2026