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Photon 4 Health® Brainhealer® Basic
EUDAMEDClass I (EU MDR)
Ref P4H-BH-BASIC-01012024Model BASIC
Identity
- Trade Name
- PHOTON 4 HEALTH® BRAINHEALER® BASIC EUDAMED
- Device Name
- PHOTON 4 HEALTH® BRAINHEALER® EUDAMED
- Model / Reference
- BASIC EUDAMEDP4H-BH-BASIC-01012024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08721398265186 EUDAMED
- Basic UDI-DI
- 10069124BHBASIC24 EUDAMED
- Direct Marketing DI
- 08721398265186 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
Photon 4 Health® Brainhealer® Basic by Photon 4 Health B.v. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 10069124BHBASIC24 | Class I | Active |
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Manufacturer
- Manufacturer
- Photon 4 Health B.v.
- EUDAMED SRN
- NL-MF-000048966
Sources (1)
- EUDAMED 5b024f86-b678-4036-b047-6bb7ff72d326 61 fields · synced Jul 14, 2026