Identity
- Trade Name
- Coolite Pro XL EUDAMED
- Device Name
- Diode Laser System EUDAMED
- Model / Reference
- GP900A8 EUDAMEDGP900A3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928258000594 EUDAMED
- Basic UDI-DI
- 69282580GP900SERIES7Z EUDAMED
- Direct Marketing DI
- 06928258000594 EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Coolite Pro XL by Shenzhen GSD Tech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Coolite Pro XL
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69282580GP900SERIES7Z | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen GSD Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000002168
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2e722fe7-a0ff-44ce-aa66-6764351d1535 61 fields · synced Jul 8, 2026