Identity
- Trade Name
- Coolite Evo EUDAMED
- Device Name
- Diode Laser System EUDAMED
- Model / Reference
- GP900A8 EUDAMEDGP900Q6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928258000426 EUDAMED
- Basic UDI-DI
- 69282580GP900SERIES7Z EUDAMED
- Direct Marketing DI
- 06928258000426 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
Category: Red-light phototherapy unit, professional
Coolite Evo by Shenzhen GSD Tech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Red-light phototherapy unit, professional.
- Lumie Brazil — Outside In (Cambridge) Ltd trading as Lumie · Class IIa
- Controller Unit (CU+) — MEDI-TECH INTERNATIONAL CORPORATION · Class II
- PRO WELLNESS — PHOTON 4 HEALTH B.V. · Class I
- Shark cryoglow — SharkNinja Operating LLC · Class IIa
- Bodyclock Luxe 700FM — Outside In (Cambridge) Ltd trading as Lumie · Class I
- BASIC MIND WELLNESS SYSTEM® — PHOTON 4 HEALTH B.V. · Class I
- Ströme Energy+ — Zero-Plus International Limited · Class IIa
- HYDRO 4 HEALTH® LASER ATP WRISTBAND — PHOTON 4 HEALTH B.V. · Class I
Manufacturer's product page: Coolite Evo3
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen GSD Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000002168
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED c436a724-c4c1-4def-8eb3-de7f376833b4 61 fields · synced Jul 13, 2026