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Diode Laser Therapy Systems
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref Alpha
Identity
- Trade Name
- Diode Laser Therapy Systems EUDAMEDFDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- Diode Laser Therapy Systems EUDAMED
- Model / Reference
- Alpha EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973663791049 EUDAMEDFDA UDI
- Basic UDI-DI
- 697366379104P9 EUDAMED
- Direct Marketing DI
- 06973663791049 EUDAMED
- 510(k) Number
- K212978 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011016 DIODE SURGICAL LASER 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
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Diode Laser Therapy Systems by BEIJING UNT Technology Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212978 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697366379104P9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- BEIJING UNT Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019748
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED 2e75c223-9483-40b6-8231-b66ae9213010 61 fields · synced Jun 18, 2026
- FDA UDI 57ba4085-f73d-4616-961d-a8b66fa3017d 33 fields · synced May 30, 2026
- FDA 510(k) K212978 1 fields · synced May 18, 2026