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Diode Laser Therapy Devices
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 8196Model HS-819
Identity
- Trade Name
- Diode Laser Therapy Devices EUDAMEDApolomed FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- Diode Laser Therapy Devices EUDAMEDDiode Laser Therapy Device FDA UDI
- Model / Reference
- HS-819 EUDAMEDFDA UDI8196 EUDAMED
- Description
- Diode Laser Therapy Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970745918196 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970745918196 EUDAMED
- 510(k) Number
- K200118 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
- Spain 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
Yes
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
No
FDA UDI
Diode Laser Therapy Devices by Shanghai Apolo Medical 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-06970745918196 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Apolo Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000002904
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 301df2f1-e8b5-4326-8013-86cfe0647ce5 61 fields · synced Jul 8, 2026
- FDA UDI fd53f8fe-4a72-481f-b26d-f6bd2b5cd33a 35 fields · synced May 30, 2026