XIAMEN SPACEGEN CO.,LTD.
China CN-MF-000018018 Last updated 8 Jun 2026
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- Devices
- 37
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
BRCA1/2 Gene Mutations Detection Kit (High Throughput Sequencing) Ref Lotus NL B.V. Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected]
K-ras Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction) Ref Lotus NL B.V. Address:Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
EGFR Gene T790M Mutation Detection Kit (Digital PCR) Ref Lotus NL B.V. Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected]
Human Pan-Cancer Drive Gene Mutations Detection Kit (High-Throughput Sequencing) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Human BCR-ABL Gene T315I Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Colorectal Cancer Related Gene Mutation Detection Kit（High Throughput Sequencing） Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Oncology Multi-Gene Mutations Detection Kit (High Throughput Sequencing) Ref Name:Lotus NL B.V. Address: Koningin Julianaplein 10,1e Verd,2595AA, The Hague,Netherlands. E-mail:[email protected]
Colorectal Cancer Related Gene Mutation Detection Kit（High Throughput Sequencing） Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
2019 Novel Coronavirus Antigen Rapid Test(Colloidal Gold) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
MGMT Gene Methylation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction) Ref Lotus NL B.V. Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected]
ALK/ROS1/RET Gene Fusion Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction) Ref Lotus NL B.V. Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected]
Human NTRK Genes Fusion Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Oncology Multi-Gene Mutations Detection Kit (High Throughput Sequencing) Ref Name:Lotus NL B.V. Address: Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected]
Breast-Ovarian Cancer Combined Gene Detection Kit Ref SPG-BOC002
BRCA1/2 Gene Mutations Detection Kit (High Throughput Sequencing) Ref Lotus NL B.V. Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected]
Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Human Glioma 26 Gene Mutations Detection Kit Ref SPG-GL001
EGFR Gene T790M Mutation Detection Kit (Digital PCR) Ref Lotus NL B.V. Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected]
Human Glioma 26 Gene Mutations Detection Kit Ref SPG-GL002
Homologous Recombination Deficiency (HRD) Panel Assay Kit Ref SPG-HRD004
Thyroid carcinoma RET Gene Fusions Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction) Ref Lotus NL B.V. Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected]
Human Endometrial Cancer Molecular Classification Detection Kit (High Throughput Sequencing) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
MLH1 Gene Methlyation Detection Kit Multiplex Fluorescence Polymerase Chain Reaction Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Human Pan-Cancer Drive Gene Mutations Detection Kit (High-Throughput Sequencing) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
K-ras Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction) Ref Lotus NL B.V. Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected]
Human Endometrial Cancer Molecular Classification Detection Kit (High Throughput Sequencing) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
EGFR Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction) Ref Lotus NL B.V. Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected]
Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Breast-Ovarian Cancer Combined Gene Detection Kit Ref SPG-BOC001
Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Human Lung Tissue Mycobacteria Identification Detection Kit (Nucleic Acid Mass Spectrometry) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
2019 Novel Coronavirus RNA Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Human PAX1 Gene Methylation Detection Kit （Multiplex Fluorescence Polymerase Chain Reaction） Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Thyroid Cancer Gene Mutation Detection Kit (High Throughput Sequencing) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Thyroid Cancer Gene Mutation Detection Kit (High Throughput Sequencing) Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
B-raf Gene Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction) Ref Lotus NL B.V. Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：[email protected]
Related companies
Authorised representatives
What XIAMEN SPACEGEN CO.,LTD. makes
The company manufactures in vitro diagnostic (IVD) kits for detecting specific gene mutations and viral antigens. Products include high-throughput sequencing and multiplex PCR-based assays for BRCA1/2, K-ras, EGFR, BCR-ABL, and other oncogenic mutations, as well as a rapid antigen test for SARS-CoV-2. Additional kits target colorectal cancer-related genes, MGMT methylation, and gene fusions like ALK, ROS1, RET, and NTRK.
These diagnostic devices fall under the IVD General category and are registered in the EU’s eudamed database. The manufacturer is based in China.
Frequently asked questions
What types of medical devices does Xiamen Spacegen Co., Ltd. manufacture?
Xiamen Spacegen Co., Ltd. specializes in in vitro diagnostic (IVD) kits designed for detecting specific gene mutations and viral antigens. Their portfolio includes high-throughput sequencing assays for oncogenic mutations like BRCA1/2, EGFR, and K-ras, as well as multiplex PCR-based kits for detecting mutations in genes such as BCR-ABL and MGMT methylation. They also produce a rapid antigen test for detecting SARS-CoV-2 using colloidal gold technology. These devices are primarily used in oncology, virology, and cancer-related diagnostics.
Where is Xiamen Spacegen Co., Ltd. based?
Xiamen Spacegen Co., Ltd. is headquartered in China. The company’s location influences its regulatory compliance requirements, particularly for devices intended for international markets like the European Union.
Which regulatory registries list Xiamen Spacegen Co., Ltd.’s devices?
Xiamen Spacegen Co., Ltd.’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry is used to track manufacturers, devices, and their regulatory status within the EU market. Listing in eudamed is a requirement for devices placed on the EU market under regulations like IVDR (In Vitro Diagnostic Regulation).
How are Xiamen Spacegen Co., Ltd.’s devices classified?
Xiamen Spacegen Co., Ltd.’s devices fall under the IVD General classification. This classification applies to most in vitro diagnostic tests, including gene mutation detection kits and antigen tests, as they are intended for general diagnostic use rather than high-risk applications like invasive procedures or implantable devices. Classification determines regulatory pathways, such as conformity assessment procedures, but does not imply approval—only individual devices undergo authorization processes.
What is the primary purpose of Xiamen Spacegen Co., Ltd.’s diagnostic kits?
The primary purpose of Xiamen Spacegen Co., Ltd.’s diagnostic kits is to detect specific genetic mutations and viral antigens for clinical decision-making. For example, their BRCA1/2 and EGFR mutation detection kits support personalized cancer treatment by identifying genetic markers associated with tumor behavior, while their SARS-CoV-2 antigen test aids in rapid infection screening. These kits are designed to assist healthcare providers in diagnosing, monitoring, or managing diseases like cancer and infectious conditions.
Information
- Country
- China
- Address
- Room 401 of 4th floor of No.2041, 7th floor of No.2043, 4th floor of No.2045, Xizhou Road, Xike Town, Tong’an District, Xiamen, China
- Website
- ispacegen.com
- [email protected]
- PRRC contact
- Feifei Guo
- EUDAMED SRN
- CN-MF-000018018