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EUDAMED last updated this device on Apr 20, 2026
0735008191CA804X20Q8CoreTherm is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by ProstaLund AB. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
07350081910051CA8042201 packaging level registered — each level carries its own UDI-DI.
07350081910051× 1 unitBase unit17350081910058× 5 units(01)07350081910051
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12160301EQUIPMENT FOR MICROWAVE PROSTATE THERMOTHERAPY5 warnings recorded — scroll inside the panel to see all entries.
There is a risk for complications if the CoreTherm® Catheter is not handled carefully and correctly. The risk for complications can be minimized by using the product as described in this instruction for use
OTHER
The CoreTherm® Catheter is intended for single use only, otherwise cross-patient urinary infection could result. Each CoreTherm® Catheter has a unique catheter serial number (SN), and the software includes a lock which prevents reuse of a catheter. Do not attempt to use a CoreTherm® Catheter for more than one treatment session.
OTHER
Primary placement in Sweden; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Nov 15, 1999 | Still on market |
| Austria | Aug 6, 2024 | Still on market |
| Denmark | Sep 7, 2000 | Still on market |
SE-MF-000004428The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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.
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.
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.