- Role
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EUDAMED update: Mar 30, 2026
US-MF-000052622US-MF-000052622Get the catalogue in Excel or CSV format — trade name, product reference, UDI and EMDN codes, legislation, quantity, last update, and more. The exact row count and price are confirmed before you pay.
1 EU importer places this manufacturer's devices
SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →No certificates registered for this manufacturer.
GenDx LLC is a medical device manufacturer registered in EUDAMED. The company has 6 devices on the EU market across 32 countries. Headquartered in San Diego, United States. Explore the regulatory profile, devices and certificates on MD Atlas.
Devices placed in 32 countries
Showing 1–6 of 6 devices.
| Product | Trade name | Reference / catalog number | Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary → | Quantity | Status |
|---|---|---|---|---|---|
| ImmunoFLOW Mycoplasma IgM Control | ImmunoFLOW Mycoplasma IgM Control | 3925 | 00613745000091 | 1 | On the market |
| ImmunoFLOW Mycoplasma pneumoniae | ImmunoFLOW Mycoplasma pneumoniae | 7005 | 00613745000060 | 1 | On the market |
| ImmunoFLOW Negative Control - Mycoplasma IgM | ImmunoFLOW Negative Control - Mycoplasma IgM | 3921 | 00613745000145 | 1 | On the market |
| ImmunoWELL JCV IgG Test | ImmunoWELL JCV IgG Test | 3810 | 00613745002231 | 1 | On the market |
| ImmunoWELL Mycoplasma Pneumoniae (IgG Antibody) | ImmunoWELL Mycoplasma Pneumoniae (IgG Antibody) | 3120 | 00613745031200 | 1 | On the market |
| ImmunoWELL Mycoplasma Pneumoniae (IgM Antibody) | ImmunoWELL Mycoplasma Pneumoniae (IgM Antibody) | 3130 | 00613745031309 | 1 | On the market |
Showing 1–6 of 6 device families.
B-00613745002231B-00613745000060B-00613745000091B-00613745000145B-00613745031309B-00613745031200