Identity
- Device Name
- 4500 PRO EUDAMED
- Model / Reference
- H4H-4500PRO-01012024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08721398265124 EUDAMED
- Basic UDI-DI
- 10069124-WELLNESS-14DR EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS 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
4500 Pro by Photon 4 Health B.v. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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-14DR | Class I | Active |
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Manufacturer
- Manufacturer
- Photon 4 Health B.v.
- EUDAMED SRN
- NL-MF-000048966
Sources (1)
- EUDAMED 5d1acc1f-9b49-4fc5-b630-2529cc0a1764 61 fields · synced Jun 18, 2026