ABINGDON HEALTH PLC
Abingdon Health | Lateral Flow CDMO Manufacturing - US & UK
Abingdon Health: International lateral flow CDMO, offering development, manufacturing and regulatory services to its clients.
- Type
- Manufacturer
- Location
- York North Yorkshire, United Kingdom
- Founded
- 2008
- Website
- https://abingdonhealth.com
- Categories
- Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- ch-active (green), checked 2026-08-12 Companies House
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- domain-registered (green), checked 2026-08-12 Domain registry record
- fda-registered (green), checked 2026-08-12 FDA
- fda-contract-manufacturer (green), checked 2026-08-12 FDA
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- registered-since (green), checked 2008-01-16 Companies House free company data product (UK)
- registered-manufacturer (green), checked 2008-01-16 Companies House free company data product (UK)
- directors-on-file (green), checked 2026-08-12 Companies House
- officer-appointed (green), checked 2026-08-12 Companies House (officers)
- leadership-on-record (green), checked 2026-08-12 Companies House (officers)
- annual-accounts-filed (green), checked 2026-08-12 Companies House (accounts)
Claimed certifications
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)