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8 products

Edan iM80 Patient Monitor Video Medical Devices & Health Equipment

Edan Instruments, Inc.

Edan iM80 Patient Monitor

15-inch high-acuity modular patient monitor with up to 13 waveforms

  • Patient Monitor
  • EU MDR Quality Management System certificate (TUV SUD, cert. no. G10 091264 0025 Rev. 01) covering Class IIb Vital Signs Monitoring Instruments - not a model-specific iM80 product certificate · Documented as compliant with IEC/EN 60601-1, 60601-2-27, -2-30, -2-34, -2-49, -2-25 and -2-51, ANSI/AAMI EC13 and ANSI/AAMI SP10 in Edan's published specification
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Sinocare Gold AQ Plus Blood Glucose Monitoring System Medical Devices & Health Equipment

Sinocare Inc.

Sinocare Gold AQ Plus Blood Glucose Monitoring System

FDA-cleared gold-electrode glucose system: 0.8 uL sample, 5-second results

  • IVD Analyser
  • FDA 510(k) K170264 - Gold AQ Blood Glucose Monitoring System platform clearance (Changsha Sinocare, Inc., 2017); Plus-specific 510(k) coverage was not separately confirmed · EN ISO 15197:2015 (per official Sinocare product page)
  • MOQ 100 pieces (per the manufacturer's own storefront listing for the Gold AQ Plus kit)
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