Identity
- Trade Name
- Huamei FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- Medical Diode Laser System EUDAMED
- Model / Reference
- HM-DL100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973512860117 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06973512860117 EUDAMED
- 510(k) Number
- K162659 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12040201 PHOTOEPILATION EQUIPMENT EUDAMED
- GMDN Term
- Dermatological diode laser 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 Diode Laser System by Shandong Huamei Technology Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-06973512860117 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shandong Huamei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025482
- Authorised Representative
- Tech4beauty GmbH DE-AR-000024345
Sources (2)
- EUDAMED 1411e5bd-cfa8-456e-9670-181739018e6d 61 fields · synced Jun 18, 2026
- FDA UDI 7bcc03eb-d4ef-45c9-b9b6-cc25014600a0 33 fields · synced May 30, 2026