Identity
- Trade Name
- Priming Set EUDAMED
- Device Name
- Infusion and priming accessories-EO EUDAMED
- Model / Reference
- F00010016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04066418000144 EUDAMED
- Basic UDI-DI
- 4066418-0000-0000-0127-UJ EUDAMED
- EMDN Code
- F0299 DIALYSIS LINES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
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
Priming Set by Fresenius Medical Care (Jiangsu) Co., Ltd. — Class IIa — 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 | 4066418-0000-0000-0127-UJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fresenius Medical Care (Jiangsu) Co., Ltd.
- EUDAMED SRN
- CN-MF-000026839
- Authorised Representative
- Fresenius Medical Care Deutschland GmbH DE-AR-000009269
Sources (1)
- EUDAMED 106943e6-0318-4b38-8e39-7add678b8ab7 61 fields · synced Oct 7, 2026