Acumen Diagnostics
Molekulardiagnostische Tests und Produkte zum Testen von Infektionskrankheiten.
Acumen Diagnostics stellt in seinem Betrieb in Singapur molekulardiagnostische Tests und Testprodukte für Infektionskrankheiten her. Das Unternehmen beliefert Gesundheitssysteme, Labore, OEM-Partner oder regulierte Exportkunden in seinen aufgeführten Hauptmärkten.
- Type
- brand seeking distribution
- Location
- Singapore
- Founded
- 2010
- Website
- acumendiagnostics.com
- Categories
- Medizin- & Gesundheitsbedarf
- Markets
- Singapur, Vereinigte Staaten, Deutschland, Australien
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)