About Sunrise Medical
Nearly four decades of FDA-cleared pathways, ISO 13485-audited manufacturing, and hospital-ready documentation for consumables used in SPD, OR, and nursing units.
Sunrise Medical entered US acute-care distribution with lot-controlled examination gloves and surgical masks.
Achieved EN 46001 certification ahead of the ISO 13485:2003 consolidation.
FDA cleared Sunrise Medical sterilization pouch and dressing families under 21 CFR 807.
Enabled hospital materials systems to scan lot genealogy for recall drills.
Notified Body audit cleared for CE-marked sterile barrier and wipe lines.
Published TCO and CO2 planning tools for infection-control fleet refresh reviews.
Every SKU packet leads with IFU, contact time, SAL notes where labeled, and Spaulding classification context.
Biocompatibility, packaging integrity, and shelf-life data are assembled for committee review—not marketing slogans.
Field service, loaner pathways, and CAPA visibility stay attached to the account after the initial award.
Clinical pathway review for infection-prevention programs.
510(k), CE MDR, and ISO 13485 audit ownership.
FSE network, MTTR targets, and parts depots.
UDI data models and capability planner tooling.
Share your care setting and SKU gaps. Sunrise Medical returns a documentation packet sized for value analysis.
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