ORGENTEC Diagnostika GmbH
DE-MF-000033178 · Germany · Mainz
ORGENTEC Diagnostika GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- Anti-Chlamydia pneumoniae IgA
- Anti-Chlamydia pneumoniae IgG
- Anti-Chlamydia pneumoniae IgM Abs.
- Anti-Chlamydia trachomatis IgA
- Anti-Chlamydia trachomatis IgG
- Anti-Chlamydia trachomatis IgM Abs.
Catalogue references include ORG 906A, ORG 906G, ORG 906MX, ORG 907A, ORG 907G, ORG 907MX.
European nomenclature codes declared: W0105010110, W0105010114, W0105010116, W0105010115, W0105010109, W0105010111.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ORGENTEC DIAGNOSTIKA GMBH (DE) · FDA 3003232042 |
| Devices in EUDAMED | 6 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ORGENTEC DIAGNOSTIKA GMBH |
What it holds in Canada
| Licences on record | 72 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 72 |
| First licensed | 2026-02-04 |
Licence types: Test Kit (70), Single Device (1), System (1).
Licensed under: ANTI-HISTONE, ENASCREEN, ANTI-PR3 HS, ANTI-SM, ANTI-RNP/SM, ANTI-SCL-70.
North American profile: Both markets. ORGENTEC Diagnostika GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V13 120500 0004 | issued | 2031-08-10 |