Galway Biomedical
Componentes de dispositivos médicos implantables y servicios de cdmo de biomateriales.
Galway Biomedical fabrica componentes de dispositivos médicos implantables y servicios CDMO de biomateriales desde sus operaciones en Galway. La empresa suministra sistemas de atención médica, laboratorios, socios OEM o clientes de exportación regulados en sus mercados primarios listados.
- Type
- brand seeking distribution
- Location
- Galway, Ireland
- Founded
- 2020
- Website
- galwaybiomedical.com
- Categories
- Suministros médicos y sanitarios
- Markets
- Irlanda, Estados Unidos, Alemania, Reino Unido
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- domain-registered (green), checked 2026-08-08 Domain registry record
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- certificate-page-on-site (amber), checked 2026-08-30 Company's own certification page
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
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)