Identity
- Trade Name
- FX 100 EUDAMED
- Device Name
- FX class dialyzers EUDAMED
- Model / Reference
- CN0219 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933291710089 EUDAMED
- Basic UDI-DI
- 4066418-0000-0000-0013-TS EUDAMED
- EMDN Code
- F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMED
Classification
- Device Class
- Class IIb 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
Fx 100 by Fresenius Medical Care (Jiangsu) 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 | 4066418-0000-0000-0013-TS | Class IIb | 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 a6923e32-93dd-4431-a982-1e277fec3496 61 fields · synced Jun 18, 2026