Comprehensive clinical trial benchmarks, low perfusion index (PI ≥ 0.2%) performance, IEC 60601-1 electrical safety, and global regulatory compliance documentation for medical device importers and B2B buyers.
BerryMed pulse oximeters undergo rigorous controlled hypoxia desaturation trials in certified clinical testing facilities following ISO 80601-2-61:2017. Arterial blood gas co-oximetry samples serve as the clinical ground truth to evaluate Root Mean Square Accuracy.
The PM6100 handheld monitor provides hospital-grade telemetry for ward spot-checks, assisted living care, and ambulatory telemetry.
| Standard / Regulatory Body | Scope & Technical Verification | Status & Compliance |
|---|---|---|
| ISO 13485:2016 | Medical Device Quality Management System for Design, Manufacturing & Quality Control | Certified / Audited |
| IEC 60601-1 (Ed. 3.1) | Basic safety and essential performance (Type BF isolated applied parts) | Full Compliance |
| IEC 60601-1-2 (4th Ed.) | EMC & Immunity in Healthcare and Home Environments | Full Compliance |
| ISO 10993-5 / -10 | Biological evaluation: cytotoxicity, irritation & sensitization | Pass / Bio-safe |
| United States FDA | FDA registration, listing & 510(k) technical dossier readiness | Registered & Ready |
| CE MDR (2017/745) | Class IIa technical documentation, CER & post-market surveillance | MDR Ready |
BerryMed utilizes multi-channel optical simulators and arterial blood co-oximetry correlation. Our sensor DSP isolates PPG waveform peaks down to PI = 0.20% with clinical Arms ≤ 2.0%.
We provide turnkey regulatory packages including ISO 14971 Risk Files, IEC 62304 Software Architecture reports, ISO 10993 Biocompatibility certificates, IEC 60601-1 safety test data, and technical files to support FDA 510(k) and CE MDR authorizations.
Yes. Shanghai Berry Electronic operates an audited ISO 13485:2016 quality management system featuring cleanrooms, automated optical testing fixtures, and component traceability.
Connect with our regulatory affairs and clinical engineering specialists for complete 510(k) dossiers, ISO 13485 certificates, or OEM/ODM sensor integration support.
Contact Regulatory Team