Identity
- Trade Name
- APOZA EUDAMED
- Device Name
- Ozone Generator EUDAMED
- Model / Reference
- Ozone DTA EUDAMED04719883750303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719883750303 EUDAMED
- Basic UDI-DI
- B-04719883750303 EUDAMED
- EMDN Code
- Z12040207 OZONE THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Apoza by Apoza Enterprise Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719883750303 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Apoza Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000033094
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED 7fd65e3b-a805-4ba8-9ca8-ea9baa63039c 61 fields · synced May 23, 2026