- Role
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EUDAMED update: May 16, 2025
US-MF-000012891US-MF-000012891SRN
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 →Devices placed in 10 countries
1 approved member
Showing 1–3 of 3 device families.
1 EU importer places this manufacturer's devices
1 authorised representative routes this manufacturer's devices
ABMRC LLC is a medical device manufacturer registered in EUDAMED. The company has 3 devices on the EU market across 10 countries. It holds 1 valid CE certificate. Headquartered in Eagan, Minnesota, United States. Explore the regulatory profile, devices and certificates on MD Atlas.
Showing 1–3 of 3 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 |
|---|---|---|---|---|---|
| BiWaze Clear System | BiWaze Clear System | BK939, BK940 | +B965BK9390 | 1 | On the market |
| BiWaze Cough | BiWaze Cough | 2037351818-21406 | +B9652037351818214060 | 1 | On the market |
| BiWaze Two Step Adapter | BiWaze Two Step Adapter | BK1443 | 00850050136019 | 1 | On the market |