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EUDAMED last updated this device on Apr 30, 2026
B-+EPIS511170Episealer Femoral Twin is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Episurf Operations AB. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
+EPIS51117051117SE-MF-0000257022156162CE01+EPIS511170
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
6 warnings recorded — scroll inside the panel to see all entries.
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 Sweden; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Mar 16, 2016 | Still on market |
| Belgium | Mar 31, 2016 | Still on market |
| Germany | Oct 10, 2016 | Still on market |
| Denmark | Jan 11, 2017 | Still on market |
| Italy | Aug 27, 2020 | Still on market |
| Netherlands | Oct 10, 2016 | Still on market |
| Norway | May 31, 2016 | Still on market |
| Poland | Mar 24, 2021 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
P090999KNEE PROSTHESES - OTHERPrimary 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 →B-+EPIS111150On the marketEpisealer Femoral TwinB-+EPIS511150On the marketEpisealer Femoral TwinB-+EPIS511250On the marketEpisealer Femoral TwinB-+EPIS511200On the marketEpisealer Knee Revision GuideB-+EPIS18100N0On the marketEpisealer Knee Revision GuideB-+EPIS181000On the marketNo certificate specifically references this device's Basic UDI-DI.
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.