Acumen Diagnostics
Molecular diagnostics assays and infectious disease testing products.
Acumen Diagnostics manufactures molecular diagnostics assays and infectious disease testing products from its Singapore operations. The company supplies healthcare systems, laboratories, OEM partners or regulated export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Singapore
- Founded
- 2010
- Website
- acumendiagnostics.com
- Categories
- Medical & Healthcare Supplies
- Markets
- Singapore, United States, Germany, Australia
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)