- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on May 29, 2026
B-04260537490224PEGA® Infuse is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Venner Medical (Deutschland) GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0426053749022460020(01)04260537490224
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12030301INFUSION PUMPS13 warnings recorded — scroll inside the panel to see all entries.
OTHER
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Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | May 20, 2021 | Still on market |
DE-MF-000005934G1 067727 0007OTHER
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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.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
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 →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 certificate specifically references this device's Basic UDI-DI.
42605374910522EEZOn the marketPEGA® COMBI LINE E with NRFit® connector42605374910526EFDOn the marketPEGA® COMBI LINE Y42605374910523YGCOn the marketPEGA® Infuse BOX 100426053749PBOX01AZOn the marketPEGA® POUCH 3426053749PPCH02AROn the marketPEGA® POUCH L426053749PPCH01APOn the marketCertificate health across this manufacturer's portfolio.
G10 067727 0011IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →