Identity
- Device Name
- AT HOME EUDAMED
- Model / Reference
- P4H-RAHOME-01012024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08721398265070 EUDAMED
- Basic UDI-DI
- 10069124-WELLNESS-8PH 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
At Home 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 | 10069124-WELLNESS-8PH | Class I | Active |
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Manufacturer
- Manufacturer
- Photon 4 Health B.v.
- EUDAMED SRN
- NL-MF-000048966
Sources (1)
- EUDAMED cb1052c1-c33d-4ac7-83ea-5c66a9bbb27e 61 fields · synced Jun 17, 2026