This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| EU | 04260033710536 | PM-U10-Test | IVD B |
| EU | 04260033710208 | CombiScreen® mALB / CREA | IVD B |
| UK | 30219 | CombiScreen Dip Check | IVD general |
| UK | 54514 | CombiScreen 12 SYS Plus | Class B – Self-testing or Near-patient Testing |
| UK | 54514 | CombiScreen 10SL | IVD general |
| US | K061846 | COMBI SCAN100 | 2007-04-06 |
| US | K061812 | COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 | 2007-04-06 |
| US | K023885 | COMBI-SCREEN, MODELS 10SL AND 11SL | 2003-10-21 |
| BR | 10009010297 | FAMÍLIA URIQUEST R120 | Class II |