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Protech's Automated Immunoassay Analyzer Secures EU IVDR Certification

Health Technology · Medical Specialties · economic_daily · 2026-08-25

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Protech's GBC CL i120 immunoassay analyzer has received EU IVDR certification, bolstering the company's international market expansion efforts.

What Happened

Certification Milestone: Protech announced that its GBC CL i120 automated chemiluminescence immunoassay analyzer has officially received EU IVDR certification, marking the first of its CLIA series to achieve this regulatory status.

Strategic Growth: This achievement validates the company's commitment to product quality and regulatory compliance, providing a strong foundation for expanding its CLIA platform and reagent sales in international markets.

Product Portfolio: The CL i120 system serves as a key platform in Protech's in-vitro diagnostics (IVD) lineup, with a wide range of reagents covering tumor markers, thyroid function, hormones, and infectious diseases.

Competitive Edge: With several CLIA reagents already approved by Taiwan's TFDA, this EU certification significantly enhances Protech's ability to scale its global operations and strengthen its position in the diagnostic equipment sector.

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