About Draeger

Founded engineering heritage in regulated medical technology · FDA Establishment registration on file · ISO 13485:2016 certified quality system.

Founded: 1889 heritage line
HQ: Telford, Pennsylvania (US ops)
Manufacturing: Global sites — US, EU, APAC
Employees: 14,000+ worldwide
FDA Establishment: On file / market-specific
UDI Issuing Agency: GS1
Primary portfolios: IVD · Infection Control · Home Care
Hospitals & labs served: Global installed base
Quality system: ISO 13485:2016

FDA Cleared (multiple 510(k) — reference-specific)
CE Marked under MDR 2017/745, Notified Body listed on DoC
ISO 13485:2016 Quality Management
IEC 60601-1 series where applicable
ISO 14971 risk management
ANSI/AAMI ST91 reprocessing alignment (consumables interfaces)