Data from EUDAMED, last updated Jun 11, 2026

Automated Nucleic Acid Extraction System

697454156003KX

3 references

IVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class A
Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd

Device family identification

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class A
Status: On the market

No device characteristics flagged

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

W02050116Nucleic acid testing integrated extraction /amplification /detection systems

References

3 references

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
AU1001-96	`AU1001-96`	`06974541565059`	1	On the market
AU1001	`AU1001`	`06974541565035`	1	On the market
AU1001S	`AU1001S`	`06974541565042`	1	On the market