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Zinexts Life Science Corp.

Active in EUDAMED

Taiwanfrom SRN EUDAMED SRN TW-MF-000026758

Devices
93
Registrations
EUDAMED

What Zinexts Life Science Corp. makes

Zinexts Life Science Corp. manufactures automated and manual nucleic acid extraction kits designed for molecular diagnostics, including viral, pathogen, and blood DNA extraction systems. Their products are tailored for high-throughput workflows, with variations supporting 48, 96, or 192 samples, and specialized formats for RNA, DNA, and formalin-fixed paraffin-embedded (FFPE) samples. The portfolio also includes kits for specific applications like coronavirus RNA extraction.

The company’s devices are classified under Class A in the EU regulatory framework and are registered in the EUDAMED database. These products are intended for use within the European Union’s medical device regulations, adhering to the requirements for low-risk in vitro diagnostic (IVD) devices. The manufacturer is based in Taiwan.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Company details

EUDAMED SRN
TW-MF-000026758
EUDAMED status
Active
EUDAMED registered name
Zinexts Life Science Corp.
Registered address
16F.,No.93, Sec. 1, Xintai 5th Rd., Xizhi Dist., 221416, New Taipei City, Taiwan
Phone
+886 2 2246 3579
PRRC contact
Theresa Lin(public in EUDAMED)

From the company website

Read 18 Sep 2026

We pioneer, develop, and produce high quality molecular diagnostics solutions. We build long-term partnerships to supply customized and expertized solutions. Most importantly, we invest in innovation and create value to increase positive impact on healthcare.

From the manufacturer's own website. Source