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EUDAMED last updated this device on Jul 23, 2026
B-07613035132207Compat Ella® Pump Universal Set ENFit® is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Cedic srl. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0761303513220712267447IT-MF-000019323G1 047541 0021(01)07613035132207
6 warnings recorded — scroll inside the panel to see all entries.
OTHER
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Italy; available across 6 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Malta | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
A030403ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USEPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.B-07613035648579On the marketCompat Ella® Pump spike set ENFit®B-07613036568029On the marketCompat Ella® Pump Spike Set ENFit®B-07613035132085On the marketCompat Ella® Spike Set ENFit®B-07613036161008On the marketCompat Ella® Universal SetB-07613035475052On the marketCOMPAT® ADAPTER ENFit TO ORAL/LUER SYRINGEB-07613287135247On the marketNo certificate specifically references this device's Basic UDI-DI.