Identity
- Trade Name
- Amika Pump Set Bag, universal, ENFit EUDAMED
- Device Name
- Enteral Giving Sets and Accessories EUDAMED
- Model / Reference
- 7751908 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250273724127 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 Pump Set Bag, universal, 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 467ae608-fc30-4960-9260-92ef516b6638 61 fields · synced Sep 17, 2026