This company has registrations in United States, Canada, Australia — 3 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 Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K251440 | CRYOcheck Chromogenic Factor VIII | 2025-08-25 |
| US | K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | 2023-09-13 |
| US | K214002 | CRYOcheck Chromogenic Factor IX | 2022-12-23 |
| CA | 35457 | ISI CALIBRATION SET | Class III |
| CA | 35458 | TRI-LEVEL INR VALIDATION SET | Class III |
| CA | 61261 | CRYOCHECK CLOT S | Class II |