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EUDAMED update: Dec 3, 2025
US-MF-000011830US-MF-000011830SRN
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 32 countries
No certificates registered for this manufacturer.
Asuragen, Inc. is a medical device manufacturer registered in EUDAMED. The company has 4 devices on the EU market across 32 countries. Headquartered in Austin, United States. Explore the regulatory profile, devices and certificates on MD Atlas.
1 approved member
1 EU importer places this manufacturer's devices
1 authorised representative routes this manufacturer's devices
No documents registered for this company yet.
Showing 1–4 of 4 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 |
|---|---|---|---|---|---|
| AmplideX DM1 Dx Kit | AmplideX DM1 Dx Kit | 76048 | 00863840000261 | 1 | On the market |
| AmplideX SMA Plus Kit (100 rxn) | AmplideX SMA Plus Kit (100 rxn) | A00056 | 00850017493025 | 1 | On the market |
| AmplideX SMA Plus Kit (50 rxn) | AmplideX SMA Plus Kit (50 rxn) | A00055 | 00863840000278 | 1 | On the market |
| QuantideX qPCR BCR-ABL minor Kit | QuantideX qPCR BCR-ABL minor Kit | 49640 | 00863840000230 | 1 | On the market |