- Role
- Country
- Date of registration
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EUDAMED last updated this device on Mar 11, 2026
B-ACK21001-C01-018ZUDr. Max Pregnancy Test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Self-testing. Manufactured by Core Technology Co., Ltd.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-ACK21001-C01-018ZUACK21001-C01-018CN-MF-000023522HL 2186929-1D-ACK21001-C01-018ZU
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
4 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.
Primary placement in Czechia; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
| Italy | — | Still on market |
| Poland | — | Still on market |
| Romania | — | Still on market |
| Slovakia | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160302HCG - RT & POCPrimary 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 →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
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-06942468138595On the marketCoretests LH Ovulation TestB-06942468131046On the marketDr. Max Ovulation TestB-ACK21003-S07-016DTOn the marketDr. Max Pregnancy Test 2in1B-ACK21001-S02-018ASOn the marketDr. Max Pregnancy Test ComfortB-ACK21001-M01-01879On the marketelkos Vivede Schwangerschafts-FrühtestB-06942468134962On 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.