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EUDAMED last updated this device on Jul 10, 2026
0851498007MATRIX12MNZMATRIX12 M is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by CIRCA Scientific, Inc.. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
US-MF-000018137(01)10851498007319
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
2 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 Belgium; available across 11 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | Mar 25, 2025 | Still on market |
| Austria | Mar 25, 2025 | Still on market |
| Germany | Mar 25, 2025 | Still on market |
| Denmark | Mar 25, 2025 | Still on market |
| Finland | Mar 25, 2025 | Still on market |
| Italy | Mar 25, 2025 | Still on market |
| Luxembourg | Mar 25, 2025 | Still on market |
| Netherlands | Mar 25, 2025 | Still on market |
| Norway | Mar 25, 2025 | Still on market |
| Poland | Mar 25, 2025 | Still on market |
| Sweden | Mar 25, 2025 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
10851498007319Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
0851498007MATRIX12MNZCS-36EPUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
1 packaging level registered — each level carries its own UDI-DI.
10851498007319× 1 unitBase unit30851498007313× 10 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
V03010299BODY TEMPERATURE MONITORING PROBES - 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 →0851498007TEMPCBL103AXOn the marketCIRCA Temperature Monitoring System0851498007CIRCAETMUSOn the marketCIRCA Temperature Monitoring System0851498007CIRCAETM3CPOn the marketS-CATH0851498007SCATHPROBEJXOn the marketS-CATH0851498007TEMPCABLEP5On the marketS-CATH M0851498007SCATHMPROBEFGOn 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.