Identity
- Trade Name
- SOLRAY EUDAMED
- Device Name
- Phototherapy Unit EUDAMED
- Model / Reference
- SOLRAY EUDAMEDAMI-CL-0711 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800042100247 EUDAMED
- Basic UDI-DI
- B-08800042100247 EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Red-light phototherapy unit, professional
Solray by Ami Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800042100247 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ami Inc.
- EUDAMED SRN
- KR-MF-000017522
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 9c59a998-e60f-4d5d-bef8-29d45f718be6 61 fields · synced Jun 20, 2026