Bioeksen AR GE Teknolojileri Anonim Şirketi
Active in EUDAMEDTürkiyefrom SRN EUDAMED SRN TR-MF-000032826
- Devices
- 150
- Registrations
- EUDAMED
DeviceDevice · Authorizations Verified Status Regime Registry Class
Bio-Speedy® SARS-CoV-2 Triple Gene RT-qPCR Kit Ref BS-SY-WCOR-308-500
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Respiratory Tract 4T RT-qPCR Kit Ref BS-RT4T-1000
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Respiratory ID-2 Panel Ref BS-RIDP-2-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Respiratory ID-3 Panel Ref BS-RIDP-3-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Respiratory Tract 4T RT-qPCR Kit Ref BS-RT4T-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Urinary Tract Antibiotic Resistance qPCR Panel Ref BS-UTABR-S-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® GAS (Group A Streptococcus) qPCR Kit Ref BS-DTC-102-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® MTB/MDR qPCR Panel Ref BS-MTBMDR-T-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Respiratory Tract RT-qPCR MX-19T Panel Ref BS-SY-MX19T-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Respiratory ID-2 Kit Ref BS-RIDK-2-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® MPXV qPCR Kit Ref BS-MPXV-96
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Human Papillomavirus Genotyping qPCR Panel Ref BS-GHPV-T-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Sepsis qPCR MX-30L Panel Ref BS-SE-MX30L-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Respiratory Tract 4T RT-qPCR Kit Ref BS-RT4T-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Respiratory ID-1 Panel Ref BS-RIDP-1-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Bordetella pertussis, B.parapertussis, B.bronchiseptica and B.holmesii Real-Time PCR Detection Kit Ref BS-DTC-103-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Respiratory Tract RT-qPCR MX-24L Panel Ref BS-SY-MX24L-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Bone & Joint qPCR Panel Ref BS-BJ-S-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Measles Virus Real-Time PCR Detection Kit Ref BS-MEV-DTC-320-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Gastroenteritis RT-qPCR MX-5T Viral Panel Ref BS-GE-MX5T-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Urinary Tract Infections qPCR Panel Ref BS-UTI-L-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® SARS-CoV-2 Triple Gene RT-qPCR Kit Ref BS-SY-WCOR-308-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Sepsis qPCR MX-30L Panel Ref BS-SE-MX30L-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Respiratory Tract RT-qPCR MX-24T Panel Ref BS-SY-MX24T-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Gastroenteritis qPCR MX-6T Parasitic Panel Ref BS-GE-MX6T-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Sexually Transmitted Infections RT-qPCR Panel Ref BS-STI-L-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® MTB/MDR qPCR Panel Ref BS-MTBMDR-T-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Human Papillomavirus Genotyping qPCR Panel Ref BS-GHPV-T-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® MTB qPCR Kit Ref BS-MTB-T-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Respiratory Tract RT-qPCR MX-24L Panel Ref BS-SY-MX24L-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Bone & Joint qPCR Panel Ref BS-BJ-T-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Candida qPCR Panel Ref BS-CD-T-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Human Papillomavirus Genotyping qPCR Panel Ref BS-GHPV-S-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Human Papillomavirus Genotyping qPCR Panel Ref BS-GHPV-L-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Human Papillomavirus High-Risk qPCR Panel Ref BS-HRHPV-L-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Bacteria/Fungi qPCR Kit Ref BS-BF-L-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Gastroenteritis RT-qPCR MX-24L Panel Ref BS-GE-MX24L-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® MTB/NTM qPCR Kit Ref BS-MTBNTM-T-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Carbapenem Resistance qPCR Kit Ref BS-AR-CR-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Gastroenteritis RT-qPCR MX-24L Panel Ref BS-GE-MX24L-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Urinary Tract Infections qPCR Panel Ref BS-UTI-T-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Urinary Tract Infections qPCR Panel Ref BS-UTI-T-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Sepsis qPCR MX-30T Panel Ref BS-SE-MX30T-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Respiratory Tract 4T RT-qPCR Kit Ref BS-RT4S-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Gastroenteritis RT-qPCR MX-24T Panel Ref BS-GE-MX24T-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Bordetella pertussis, B.parapertussis, B.bronchiseptica and B.holmesii Real-Time PCR Detection Kit Ref BS-DTC-103-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Sexually Transmitted Infections RT-qPCR Panel Ref BS-STI-T-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® MRSA qPCR Kit Ref BS-MRSA-T-25
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® SARS-CoV-2 N RT-qPCR Kit Ref BS-SY-WCOR-306-250
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBio-Speedy® Human Papillomavirus 6-11-16-18-HR qPCR Kit Ref BS-4THPV-100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
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Company details
- EUDAMED SRN
- TR-MF-000032826
- EU VAT number
- 1760932853
- EUDAMED status
- Active
- EUDAMED registered name
- Bioeksen AR GE Teknolojileri Anonim Şirketi
- Registered address
- Huzur Mahallesi, 34475, İstanbul, Türkiye
- Website
- www.bioeksen.com.tr/
- linkedin.com/company/bioeksen
- [email protected]
- Phone
- +90 212 285 10 17
- PRRC contact
- Onur Kaya(public in EUDAMED)
EUDAMED certificates1
1 certificate·1 valid, 0 expired·IVDR 1·next expiry 9 Jun 2031
BSI Group The Netherlands B.V. 2797 ·1 certificate
- IVDR 810528 Active
Quality management system ·EU IVDR
- Issued
- 10 Jun 2026
- Expires
- 9 Jun 2031
Related companies
Certifiers
- BSI Group The Netherlands B.V. 2797
From the company website
Read 18 Oct 2026
Bioeksen specializes in innovative molecular diagnostic solutions for human health, animal health, food safety, and plant health. Discover our high-quality products and technologies, including qPCR systems, sample prep solutions, and diagnostic kits designed for precise and efficient testing.
From the manufacturer's own website. Source