Skip to content

Bioeksen AR GE Teknolojileri Anonim Şirketi

Active in EUDAMED

Türkiyefrom SRN EUDAMED SRN TR-MF-000032826

Devices
150
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate

Catalogue150

Newest first, rows 1-50 of 150

Search and filter all 150 devices
Skip device list

Rows 1-50 of 150

Showing 1-50 of 150

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
Phone
+90 212 285 10 17
PRRC contact
Onur Kaya(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredIVDR 1next expiry 9 Jun 2031

EUDAMED certificates (1)

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

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

Frequently asked questions

How many devices does Bioeksen AR GE Teknolojileri Anonim Şirketi have in the registry?

The registry currently lists 150 devices for Bioeksen AR GE Teknolojileri Anonim Şirketi. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bioeksen AR GE Teknolojileri Anonim Şirketi's devices?

Among its 50 most recently registered devices, Bioeksen AR GE Teknolojileri Anonim Şirketi has devices listed in EUDAMED (50 devices).

What risk classes do Bioeksen AR GE Teknolojileri Anonim Şirketi's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Bioeksen AR GE Teknolojileri Anonim Şirketi's devices are IVDR Class A and IVD general. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Bioeksen AR GE Teknolojileri Anonim Şirketi?

EUDAMED lists 1 certificate for Bioeksen AR GE Teknolojileri Anonim Şirketi (quality management system) under IVDR. 1 is recorded with the status issued. The most recent was issued on 10 Jun 2026.

What are the newest devices from Bioeksen AR GE Teknolojileri Anonim Şirketi in the registry?

The most recently registered devices listed for Bioeksen AR GE Teknolojileri Anonim Şirketi include Bio-Speedy® Human Papillomavirus Genotyping qPCR Panel, Bio-Speedy® Gastroenteritis qPCR MX-6L Parasitic Panel, Bio-Speedy® MRSA qPCR Kit and Bio-Speedy® Sexually Transmitted Infections RT-qPCR Panel.

Generated automatically from registry data and not verified by a human reviewer.