Yourgene Health UK Ltd
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED SRN GB-MF-000024810
- Devices
- 21
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
Yourgene QST*R Plus XY Ref AN0XYB2
Yourgene® Insight DPYD (100T) Ref PGX-1806-100
Yourgene® Cystic Fibrosis Plus UK Ref CF1UKB1
Yourgene® QST*R Plus Trisomy 21 Ref AN021BX
Yourgene® Insight DPYD (25T) Ref PGX-1806-25
Yourgene® Cystic Fibrosis Lite Ref CF4HTB1
Yourgene® Thrombosis Risk Panel Ref THF04B2
Yourgene® QST*R Plus Trisomy 18 Ref AN018BX
Yourgene® Male Factor Infertility Base Ref AZFXYB1
Yourgene® Male Factor Infertility Plus Ref AZFPLBX
Yourgene® DPYD Ref ONDYDB1
Yourgene® Cystic Fibrosis Plus Iberian Ref CFIBNB1
Yourgene® Cystic Fibrosis Base Germany Ref CF1DEB2
Yourgene® QST*R Plus Trisomy 13 Ref AN013BX
Yourgene® Cystic Fibrosis Plus Italian Ref CFITAB1
Yourgene® QST*R Pregnancy Loss Ref AN6XYB1
IONA® Test AR (including software) Ref 10141020
IONA® test M (including software) Ref 10141010
Yourgene® Cystic Fibrosis Base Ref CF2EUB2
Yourgene® QST*R Base Ref AN0PLB2
Company details
- EUDAMED SRN
- GB-MF-000024810
- EU VAT number
- GB160750328
- EUDAMED status
- Active
- EUDAMED registered name
- Yourgene Health UK Ltd
- EUDAMED abbreviated name
- Yourgene Health
- Registered address
- Skelton House, Lloyd Street North, M15 6SH, Manchester, United Kingdom (ex Northern Ireland)
- Website
- www.yourgenehealth.com
- [email protected]
- Phone
- + 44 (0)161 669 8122
- PRRC contact
- Claire Ryan
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 31 Oct 2028
Notified body 2797 1 certificate
- IVDR 754552 Supplemented
Quality management system EU IVDR
- Issued
- 13 Feb 2025
- Expires
- 31 Oct 2028
- Reason
- Add device or group
From the company website
Yourgene Health, an integrated technologies and services business, enabling the delivery of genomic medicine. Our Expertise: Yourgene has >10 years of experience and expertise in liquid biopsy through NIPT, sample preparation and now precision medicine.
Frequently asked questions
How many devices does Yourgene Health UK Ltd have in the registry?
The registry currently lists 21 devices for Yourgene Health UK Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Yourgene Health UK Ltd's devices?
Among its 21 most recently registered devices, Yourgene Health UK Ltd has devices listed in EUDAMED (21 devices).
What risk classes do Yourgene Health UK Ltd's devices fall under?
Among its 21 most recently registered devices, the classes recorded for Yourgene Health UK Ltd's devices are IVDR Class C, IVD general and IVD Annex II List B. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Yourgene Health UK Ltd?
EUDAMED lists 1 certificate for Yourgene Health UK Ltd (quality management system) under IVDR. The most recent was issued on 2025-02-13.
What are the newest devices from Yourgene Health UK Ltd in the registry?
The most recently registered devices listed for Yourgene Health UK Ltd include Yourgene QST*R Plus XY, Yourgene® Insight DPYD (100T), Yourgene® Cystic Fibrosis Plus UK and Yourgene® QST*R Plus Trisomy 21.