Identity
- Device Name
- BOTTLE 9000 EUDAMED
- Model / Reference
- H4H-BOT9000-01012024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08721398265155 EUDAMED
- Basic UDI-DI
- 10069124-WELLNESS-16DV 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
Bottle 9000 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-16DV | Class I | Active |
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Manufacturer
- Manufacturer
- Photon 4 Health B.v.
- EUDAMED SRN
- NL-MF-000048966
Sources (1)
- EUDAMED c32401d8-0fc3-4cd9-b4f9-b094270650e2 61 fields · synced Jul 8, 2026