- Role
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LU-MF-000000128F401 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by B Medical Systems S.à r.l.. Placed on the EU market in Norway. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Feb 24, 2026
05450104511097B6Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05450104543463
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
8 warnings recorded — scroll inside the panel to see all entries.
Described in instructions for use
Described in instructions for use
Described in instructions for use
Described in instructions for use
Related ISO15223-1 symbol mentioned on dataplate
Described in instructions for use
Described in instructions for use
Described in instructions for use
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 Norway; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| NorwayPrimary placement | Mar 29, 2019 | Still on market |
| Austria | — | Still on market |
| Belgium | Jun 14, 2019 | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | Jul 15, 2025 | Still on market |
| Czechia | — | Still on market |
| Germany | Jul 12, 2019 | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | Jun 20, 2019 | Still on market |
| Finland | — | Still on market |
| France | Aug 8, 2019 | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | Dec 14, 2023 | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | Mar 20, 2020 | Still on market |
| Luxembourg | Jun 12, 2019 | Still on market |
| Latvia | Oct 25, 2019 | Still on market |
| Malta | — | Still on market |
| Netherlands | Oct 25, 2023 | Still on market |
| Poland | Oct 29, 2019 | Still on market |
| Portugal | — | Still on market |
| Romania | Nov 27, 2020 | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | Dec 16, 2024 | Still on market |
| Türkiye | Jul 25, 2023 | Still on market |
| XI | — | 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.
05450104543463Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
05450104511097B6991.8500.**UDI 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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z121702BLOOD AND BLOOD COMPONENTS FREEZERSNo 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.No certificate specifically references this device's Basic UDI-DI.