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Certifications

TÜV SÜD: EC Certificate (Devices for Phototherapy and Iontophoresis acc. MDD Appendix II)

TÜV SÜD: DIN EN ISO 13485 (Quality Management System for Medical Devices)

QVH Service GmbH: Pre-Qualification acc. § 126 SGB V (German Law - Qualified Supply of Durable Medical Equipment)

U.S. Food and Drug Administration: 510(k) Premarket Notification for Saalio/The Fischer