Identity
- Trade Name
- Dora EUDAMED
- Device Name
- Hemodialysis Machine EUDAMED
- Model / Reference
- DORA-6000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974325110017 EUDAMED
- Basic UDI-DI
- 69743251108784Y2 EUDAMED
- EMDN Code
- Z12090201 HAEMODIALYSIS EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Dora by Guangzhou Phoenix Medical Equipment Co., LTD. — Class IIb — 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 | 69743251108784Y2 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Guangzhou Phoenix Medical Equipment Co., LTD.
- EUDAMED SRN
- CN-MF-000012210
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED b6f9ddc6-0be5-463d-b6f7-9a5124e9ee4a 61 fields · synced Oct 6, 2026