This company holds 19 NMPA certificates in China and has registrations in European Union, United Kingdom — 2 overseas markets.
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 Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| CN | 桂械注准20242400280 | 血红蛋白试纸(电化学法) | Class II |
| CN | 桂械注准20232400142 | 血糖质控液 | Class II |
| CN | 桂械注准20212400019 | 血糖试纸(电化学法) | Class II |
| CN | 桂械注准20212400018 | 血红蛋白试纸(电化学法) | Class II |
| EU | 06971913783714 | MINDMED | ivd-annex-ii-list-b |
| EU | D-697191378-TCTSHS | ACCU-ANSWER | ivd-devices-self-testing |
| EU | D-697191378-UATSHP | ACCU-ANSWER | ivd-devices-self-testing |
| EU | D-697191378-HTSKG | ACCU-ANSWER | ivd-devices-self-testing |
| UK | 53307 | Blood Glucose Test Strips | IVD Devices for Self-Testing |
| UK | 62537 | Blood Glucose Meters | IVD Annex II List B |
| UK | 57273 | Hemoglobin Test Strips | IVD Devices for Self-Testing |