Acumen Diagnostics
Tests de diagnostic moléculaire et produits de test de maladies infectieuses.
Acumen Diagnostics fabrique des tests de diagnostic moléculaire et des produits de test de maladies infectieuses à partir de ses opérations de Singapour. La société fournit des systèmes de santé, des laboratoires, des partenaires OEM ou des clients exportateurs réglementés sur ses principaux marchés cotés.
- Type
- brand seeking distribution
- Location
- Singapore
- Founded
- 2010
- Website
- acumendiagnostics.com
- Categories
- Fournitures médicales et de santé
- Markets
- Singapour, États-Unis, Allemagne, Australie
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-03 Mail server of the company domain
- domain-registered (green), checked 2026-08-03 Domain registry record
- web-presence-since (green), checked 2026-08-04 Internet Archive (Wayback)
- sanctions-clear (green), checked 2026-08-03 OpenSanctions
- debarment-clear (green), checked 2026-08-03 OpenSanctions
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)