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Photon 4 Health® Brainhealer® Gutbrain® Basic
EUDAMEDClass I (EU MDR)
Ref P4H-GB-BASIC-01012024Model GUTBRAIN BASIC
Identity
- Trade Name
- PHOTON 4 HEALTH® BRAINHEALER® GUTBRAIN® BASIC EUDAMED
- Device Name
- PHOTON 4 HEALTH® BRAINHEALER® EUDAMED
- Model / Reference
- GUTBRAIN BASIC EUDAMEDP4H-GB-BASIC-01012024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08721398265216 EUDAMED
- Basic UDI-DI
- 10069124GUTBRAINBASICFY EUDAMED
- Direct Marketing DI
- 08721398265216 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® Gutbrain® 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 | 10069124GUTBRAINBASICFY | Class I | Active |
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Manufacturer
- Manufacturer
- Photon 4 Health B.v.
- EUDAMED SRN
- NL-MF-000048966
Sources (1)
- EUDAMED 4e3200b6-6357-4348-99f2-68dbfa991f79 61 fields · synced Jul 21, 2026