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BGI EUROPE A/S

Denmark DK-MF-000014089 Last updated 17 Sep 2026

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Devices
69
Registries
EUDAMED
FDA recalls
0

Catalogue69

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EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • V13 125836 0004 Issued

    Quality management system EU IVDR

    Issued
    29 Jun 2026
    Expires
    28 Jun 2031

Related companies

Notified bodies

About

As the founder of the Chinese gene industry, and with its mission of “genetic science and technology for the benefit of humanity”, China has developed a network of marketing services covering more than 100 countries and autonomous regions of all provinces and cities around the world, becoming a small number of industry-wide, applied technology companies, a technologically advanced, well-equipped and large-scaled multi-group-output platform, which has become an invaluable provider of science and technology and provider of accurate medical services worldwide。

Translated from the manufacturer's own website. Source

What BGI EUROPE A/S makes

BGI Europe A/S manufactures in vitro diagnostic (IVD) kits and software for nucleic acid extraction, pathogen detection, genetic mutation analysis, and methylation testing. Key products include kits for HPV typing, EGFR/KRAS/ALK gene mutation detection, and chromosome aneuploidy analysis, alongside software tools for cancer mutation analysis and pathogen identification. The company also provides liquid chromatography-tandem mass spectrometry-based kits for amino acid and carnitine detection.

These devices fall under Class A and IVD Annex II List B classifications, with some listed under IVD General regulations. The products are registered in the EU’s eudamed database. The manufacturer is based in Denmark.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does BGI Europe A/S manufacture?

BGI Europe A/S specializes in in vitro diagnostic (IVD) devices, primarily nucleic acid extraction/isolation kits. Their portfolio includes diagnostic kits for detecting genetic mutations (such as EGFR/KRAS/ALK), infectious pathogens (e.g., central nervous system pathogens), and genetic disorders (e.g., thalassemia or chromosome aneuploidy). They also develop software tools for genetic analysis, such as cancer mutation detection and HPV typing. These products are designed for molecular diagnostics, genetic screening, and pathogen identification.

Where is BGI Europe A/S based, and how does that affect its regulatory compliance?

BGI Europe A/S is headquartered in Denmark, which places its devices under EU regulatory oversight. Since these products are classified as IVDs, they must comply with EU IVD Regulation (EU 2017/746) requirements, including registration in the eudamed database. The company’s Danish location ensures alignment with EU regulatory standards, though individual device classifications (e.g., Class A or IVD Annex II List B) determine specific compliance obligations.

Which EU regulatory registries list BGI Europe A/S’s devices?

BGI Europe A/S’s devices are registered in the eudamed database, the official EU portal for tracking in vitro diagnostic (IVD) medical devices. This registry is maintained under EU IVD Regulation (EU 2017/746) to ensure transparency and traceability of authorized products. While eudamed is the primary listing, specific device classifications (e.g., Class A or Annex II List B) may also require additional national or EU-level documentation, depending on the risk level.

How are BGI Europe A/S’s devices classified under EU regulations?

BGI Europe A/S’s devices fall into multiple EU IVD classification categories: Class A (lowest risk, e.g., some nucleic acid kits), IVD Annex II List B (moderate risk, e.g., genetic mutation detection kits), and IVD General (standard regulatory pathway). Classification is determined by factors like intended use, clinical risk, and diagnostic purpose. For example, a HPV typing kit or EGFR/KRAS/ALK mutation detection kit would likely fall under Annex II List B due to their role in diagnosing or monitoring serious conditions, requiring stricter regulatory scrutiny.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Denmark
Address
34, Symfonivej , Herlev, Denmark
Website
www.bgi.com
Phone
+457260806
PRRC contact
Yexia Zou
EUDAMED SRN
DK-MF-000014089