Identity
- Trade Name
- K-Zero Extension EUDAMED
- Device Name
- IV Extension Lines EUDAMED
- Model / Reference
- M78401045Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250273752946 EUDAMED
- Basic UDI-DI
- 42502737NIV50212a000000WN EUDAMED
- EMDN Code
- A03020102 HIGH PRESSURE EXTENSION LINES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
K-Zero Extension by Fresenius Kabi AG — 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 | 42502737NIV50212a000000WN | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fresenius Kabi AG
- EUDAMED SRN
- DE-MF-000009273
Sources (1)
- EUDAMED 211b9217-d50e-431e-afb9-b518469448c5 61 fields · synced Jul 29, 2026