Medical Device Registrations
NMPA Class II product registrations for Nanjing Progene Biotechnology, cross-checked against Chinese medical-device databases.
Registered products
| Product | Registration number | Method | Class |
|---|---|---|---|
| Insulin assay kit (胰岛素测定试剂盒) | 苏械注准 20252400015 | Quantum-dot immunofluorescence | II (IVD) |
| Urine microalbumin assay kit (尿微量白蛋白测定试剂盒) | 苏械注准 20252400223 | Quantum-dot immunofluorescence | II (IVD) |
| hCG test kit (人绒毛膜促性腺激素检测试剂盒) | Class II — Jiangsu MPA | Colloidal gold | II (IVD) |
Manufacturing license
| License number | 苏药监械生产许20240173号 (Jiangsu medical device production license) |
|---|---|
| Holder | Nanjing Progene Biotechnology Co., Ltd |
| Legal representative | Cao Lei (曹雷) |
| Production address | No. 26, Hengguang Road, Nanjing Economic and Technological Development Zone |
Verification sources
- Yaozh Medical Device Data (药智医械数据, db.yaozh.com) — NMPA registration records
- Wuxu Medical Device Data (戊戌数据) — manufacturer and registration records
- VBData (动脉网) — NMPA Class II approval records
Registration numbers are recorded as published in Chinese medical-device databases; verify the current status in the NMPA database before relying on them for a purchase decision.
By Progene Bio Regulatory Affairs Team · Medical disclaimer · Last reviewed: 2026-09-13