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EUDAMED update: Mar 6, 2026
CN-MF-000021843Amoy Diagnostics Co., LTD. is a medical device manufacturer registered in EUDAMED. The company has 3 devices on the EU market across 2 countries. Headquartered in Xiamen, China. Explore the regulatory profile, devices and certificates on MD Atlas.
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 →CN-MF-000021843SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →BE-CA-007No certificates registered for this manufacturer.
No documents registered for this company yet.
1 approved member
PRRC
Showing 1–3 of 3 devices.
| Trade name | Reference / catalog number | UDI-DI code | Quantity | Status |
|---|---|---|---|---|
| AmoyDx® AutoExtract Kit (Circulating DNA) | 8.02.0148 | 06959094214869 | 1 | On the market |
| AmoyDx® AutoExtract Kit (FFPE DNA) | 8.02.0147 | 06959094214838 | 1 | On the market |
| AmoyDx® AutoExtract Kit (FFPE DNA/RNA) | 8.02.0145 | 06959094214692 | 1 | On the market |
Devices placed in 2 countries