Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Amika Varioline, ENFit — Class IIa MDR by Fresenius Kabi AG

MD Atlas
Fresenius Kabi AG

EUDAMED last updated this device on Mar 10, 2026

Amika Varioline, ENFit

42502737NEN60312a000000H4

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fresenius Kabi AG
UDI-DI code: 04250273723854
Reference / catalog number: 7751902

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Fresenius Kabi AG
SRN: DE-MF-000009273
Manufacturer status: Active

Critical warnings

5 warnings recorded — scroll inside the panel to see all entries.

CW011
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: Amika Varioline, ENFit
UDI-DI code: 04250273723854
Basic UDI-DI: 42502737NEN60312a000000H4
Reference / catalog number: 7751902
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A03010302ENTERAL FEEDING PUMP CONTROLLERS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Ambix NONCORstick® Safe 20Gx14mm max 21 bar/300 psi-max 4ml/s42502737NIV51112a000000WQOn the market Amika Pump Set Bag, universal, ENFit42502737NEN60312a000000H4On the market Freeflex+ Transfer Adapter42502737NIV50611s000000BCOn the market Freka® Universal Funnel Adaptor, ENFit42502737NEN60011x000000RZOn the market 775154142502737NEN60011x000000RZOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.