Identity
- Trade Name
- AV-Set B INF-E EUDAMED
- Device Name
- 5008 haemodialysis tubing sets EUDAMED
- Model / Reference
- F00010026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04066418000229 EUDAMED
- Basic UDI-DI
- 4066418-0000-0000-0114-U4 EUDAMED
- EMDN Code
- F020102 ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES 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
AV-Set B INF-E by Fresenius Medical Care (Jiangsu) Co., Ltd. — Class IIa — CE/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 | 4066418-0000-0000-0114-U4 | 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 d4e58d3a-0f19-4143-a90e-d4bb256ac089 61 fields · synced Oct 6, 2026