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DE-MF-000009705Instrument module MODULA-HANSEAT M is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by G. Heinemann Medizintechnik GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Mar 24, 2026
0426054893INC2SPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04260548932539
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 Germany; available across 23 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jan 1, 2004 | Mar 31, 2028 |
| Austria | Jan 1, 2004 | Mar 31, 2028 |
| Czechia | Jan 1, 2004 | Mar 31, 2028 |
| Estonia | Jan 1, 2004 | Mar 31, 2028 |
| Spain | Jan 1, 2004 | Mar 31, 2028 |
| Finland | Jan 1, 2004 | Mar 31, 2028 |
| France | Jan 1, 2004 | Mar 31, 2028 |
| Croatia | Jan 1, 2004 | Mar 31, 2028 |
| Hungary | Jan 1, 2004 | Mar 31, 2028 |
| Ireland | Jan 1, 2004 | Mar 31, 2028 |
| Iceland | Jan 1, 2004 | Mar 31, 2028 |
| Italy | Jan 1, 2004 | Mar 31, 2028 |
| Lithuania | Jan 1, 2004 | Mar 31, 2028 |
| Latvia | Jan 1, 2004 | Mar 31, 2028 |
| Norway | Jan 1, 2004 | Mar 31, 2028 |
| Poland | Jan 1, 2004 | Mar 31, 2028 |
| Portugal | Jan 1, 2004 | Mar 31, 2028 |
| Romania | Jan 1, 2004 | Mar 31, 2028 |
| Sweden | Jan 1, 2004 | Mar 31, 2028 |
| Slovenia | Jan 1, 2004 | Mar 31, 2028 |
| Slovakia | Jan 1, 2004 | Mar 31, 2028 |
| Türkiye | Jan 1, 2004 | Mar 31, 2028 |
| XI | Jan 1, 2004 | Mar 31, 2028 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
04260548932539Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
0426054893INC2S0300-20000UDI 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.
Q0399ENT DEVICES - OTHERCertificate health across this manufacturer's portfolio.
1224GB448241107IssuedNotified 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 →No certificate specifically references this device's Basic UDI-DI.
0426054893MOD3KOn the marketENT treatment unit MODULA-M0426054893MOD3KOn the marketInstrument module MODULA-HANSEAT L0426054893INC2SOn the marketInstrument module MODULA-HANSEAT XL0426054893INC2SOn the marketInstrument module MODULA-ICL0426054893INC2SOn the marketInstrument module MODULA-ICM0426054893INC2SOn the market