Quality & Regulatory
Certifications & Regulatory
CE-marked lines, ISO 13485 quality management, and China medical device manufacturing registration for Nanjing Progene Biotechnology.
CE Marking
| Declaration | EC Declaration of Conformity — IVDD 98/79/EC (amended 2007/47/EC) |
|---|---|
| Conformity procedure | Annex III (self-declaration, "Others" classification) |
| Authorized Representative | MedPath GmbH, Munich, Germany |
| AR notification valid until | 07.06.2028 |
| Applied standards | EN ISO 14971, EN ISO 15223-1, EN ISO 13485:2016, EN ISO 18113-1/3 |
CE-marked lines: HIV, FOB, COC, MET, MOP, KET, MDMA, THC, Multi-Drug, LH, hCG, Syphilis, H. pylori, Malaria, Dengue, COVID-19/Influenza A+B (per the Authorized Representative notification).
ISO 13485
| Standard | GB/T 42061-2022 / ISO 13485:2016 |
|---|---|
| Scope | Design, development, manufacture & distribution of IVD test kits and associated reagents (protein, hormone, enzyme, vitamin) |
China Registration & Licenses
| Manufacturing license | 苏药监械生产许20240173号 (SYJXSCX20240173) |
|---|---|
| Export certificate | 苏宁药监械出20252501号 (SNYJXC20252501), valid until 2027-03-06 |
| Business license | 91320102339445594H |
| Issuing authority | Jiangsu Medical Products Administration (江苏省药品监督管理局) |
Certificate Gallery
Certificate documents are available on request for buyer qualification.