Identity
- Device Name
- Photizo EUDAMED
- Model / Reference
- Skincare EUDAMEDphc-skincare EUDAMEDphc-skin EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009900149134 EUDAMED
- Basic UDI-DI
- 60099001491skin8E EUDAMEDB-06009900149134 EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Photizo by Photon Therapy Systems (Pty) Ltd — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Red-light phototherapy unit, professional.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 60099001491skin8E | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 60099001491skin8E | Class IIa | Active |
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Manufacturer
- Manufacturer
- Photon Therapy Systems (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000037447
- Authorised Representative
- TNMC Devices Llc HR-AR-000019582
Sources (2)
- EUDAMED 129aebed-c8a3-4c88-883e-39890da7d9b1 61 fields · synced Jun 19, 2026
- EUDAMED 328f1358-8234-448e-afa9-423aad7b1591 61 fields · synced May 17, 2026