- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 19, 2026
B-04058863012162Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →XVIVO Disposable Lung Circuit "BIOLINE COATING" SWE is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by Maquet Cardiopulmonary GmbH. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →04058863012162Basic 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 →B-04058863012162701069387UDI 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 →(01)04058863012162
European Medical Device Nomenclature — the EU product classification assigned to this device.
C03010301CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO)1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Sweden; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Still on market |
DE-MF-000020091Certificate health across this manufacturer's portfolio.
G15 067154 0016IssuedNotified 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 →50008-16-10405886357664FEOn the market016061 Holder arm405886357664FEOn the market016062 Holder for Oxygenator405886357664FEOn the market016062 Holder for Oxygenator405886357664FEOn the marketArt. HLS cannula OD = 13 Fr (4.3 mm) 3/8" connector with LL, insertion length 15 cmB-04037691736587On the market