Identity
- Device Name
- MIND WELLNESS SYSTEM® EUDAMED
- Model / Reference
- P4H-MINDWS-01012024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08721398265001 EUDAMED
- Basic UDI-DI
- 10069124-WELLNESS-13DP EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Mind Wellness System® by Photon 4 Health B.v. — Class I — 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
- Shark cryoglow — SharkNinja Operating LLC · Class IIa
- Bodyclock Luxe 700FM — Outside In (Cambridge) Ltd trading as Lumie · Class I
- Ströme Energy+ — Zero-Plus International Limited · Class IIa
- SOLRAY — AMI INC. · Class IIa
- Lumie Soleil — Outside In (Cambridge) Ltd trading as Lumie · Class IIa
- Energy Lightpad — Zero-Plus International Limited · Class IIa
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 | 10069124-WELLNESS-13DP | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Photon 4 Health B.v.
- EUDAMED SRN
- NL-MF-000048966
Sources (1)
- EUDAMED d425bfb5-3c8e-44a9-9674-6201f0175772 61 fields · synced Jul 12, 2026