Identity
- Trade Name
- Amika Varioline, ENFit EUDAMED
- Device Name
- Enteral Giving Sets and Accessories EUDAMED
- Model / Reference
- 7751902 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250273723854 EUDAMED
- Basic UDI-DI
- 42502737NEN60312a000000H4 EUDAMED
- EMDN Code
- A03010302 ENTERAL FEEDING PUMP CONTROLLERS 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
Amika Varioline, ENFit 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 | 42502737NEN60312a000000H4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fresenius Kabi AG
- EUDAMED SRN
- DE-MF-000009273
Sources (1)
- EUDAMED 3b925d4b-2c7c-44a0-9cc9-ece31088acb5 61 fields · synced Jul 9, 2026