NimaGen BV
Netherlands NL-MF-000022926 Last updated 21 Oct 2026
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- Devices
- 6
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Unique Dual Index Plate for Illumina® Ref IDX096-U0X(X)-I
Tumour Protein p53 gene (TP53) Library Prep Kit for Illumina® Ref RC-TP53096-I
About
DNA Sequencing Solutions that Help Genomics Laboratories Create Value for Their Customers...
What NimaGen BV makes
NimaGen BV manufactures library preparation kits designed for next-generation sequencing (NGS) on the Illumina platform. These include targeted gene panels such as BRCA1, BRCA2, TP53, CFTR, and PALB2, as well as a dual-index plate for Illumina sequencing workflows. The kits are tailored for genomic analysis in research and clinical settings, enabling focused sequencing of specific genes linked to conditions like cancer and cystic fibrosis.
The company’s products fall under the EU In Vitro Diagnostic Medical Device (IVD) General category and are registered in the EU’s eudamed database. NimaGen BV is based in the Netherlands, adhering to EU regulatory requirements for IVDs.
Frequently asked questions
What does NimaGen BV make?
NimaGen BV manufactures library preparation kits for next-generation sequencing on the Illumina platform, including targeted gene panels for BRCA1, BRCA2, TP53, CFTR, and PALB2, as well as a Unique Dual Index Plate for Illumina sequencing workflows. These products are designed for genomic analysis in research and clinical settings.
Where is NimaGen BV based?
NimaGen BV is based in the Netherlands, as indicated by its country code NL in the device data. The company operates within the EU regulatory framework for in vitro diagnostic medical devices.
Which registries list NimaGen BV's devices?
NimaGen BV's devices are listed in the EU's eudamed database, which is the official system for registering medical devices and in vitro diagnostic products under EU regulations. This registration confirms their inclusion in the EU's regulatory oversight framework.
How are NimaGen BV's devices classified?
NimaGen BV's devices are classified under the EU In Vitro Diagnostic Medical Device (IVD) General category. This classification applies to products used for in vitro examination of specimens from the human body, such as blood or tissue samples, to provide information for diagnostic, monitoring, or compatibility purposes.
Information
- Country
- Netherlands
- Address
- 88, Hogelandseweg, Nijmegen, Netherlands
- Website
- www.nimagen.com
- linkedin.com/company/nimagen-bv
- [email protected]
- Phone
- +31248200241
- PRRC contact
- N/A N/A
- EUDAMED SRN
- NL-MF-000022926