About Draeger

About Draeger

Draeger is presented here as a technical medical-device partner for organizations that need defensible documentation, controlled service practices, and disciplined portfolio coverage across laboratory, infection-control, and home-care equipment. The site is intentionally data-forward: decision makers can see the operating facts, regulatory posture, and documentation expectations before they schedule a conversation. That approach fits hospital value analysis committees, biomed engineering groups, laboratory directors, and post-acute program leads who need fewer claims and more reviewable inputs.

Founded
1889 heritage, modernized for connected care programs
HQ orientation
Global medical technology operations with regional support hubs
Portfolio focus
IVD laboratory equipment, infection-control consumables, home and rehabilitation care
Quality system
ISO 13485 oriented device lifecycle controls
FDA Establishment
30XXXXXXX reference placeholder for buyer documentation
UDI issuing agency
GS1-aligned traceability planning
Service model
FSE dispatch, CMMS reporting, PM plans, and cybersecurity advisory workflow
Interoperability
HL7, LIS middleware, device documentation, and secure data-transfer review
Hospitals served
Multi-site procurement and care-setting standardization programs

Certifications and recognition areas

The list below is written as a procurement-facing index. Actual market clearance, model coverage, indication, and service scope should always be confirmed in the project documentation packet for the specific device family under review.

  • FDA cleared pathways where applicable, with 510(k) summary review available by product family
  • CE Mark under MDR 2017/745 or IVDR 2017/746 when the device scope requires European documentation
  • ISO 13485:2016 medical device quality management system orientation
  • IEC 60601-1 electrical safety and IEC 60601-1-2 EMC planning for powered medical systems
  • ANSI/AAMI ST91 and infection-control workflow references for reprocessing-related programs
  • RoHS, REACH, material compliance, and packaging documentation for supply-chain review

Need the documented view instead of the brochure view?

Ask for device-specific evidence, service scope, and compatibility notes for your committee packet.

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