MDSAP CERTIFICATE

MDSAP CERTIFICATE

Product catalog summary
MDSAP Certificate Overview
This document is an MDSAP certificate issued to INDUSTRIA ZINGARDI S.R.L., confirming their compliance with ISO 13485:2016 and various regulatory requirements for medical devices in Canada and the United States.
Certificate Details
  • Certificate Number: 008.24-0/MDSAP
  • Facility ID: F007336
  • Location: Via Mazzini 161, 15067 Novi Ligure (AL), Italy
Regulatory Compliance
  • Canada: Medical Devices Regulations – Part 1- SOR 98/282
  • United States: 21 CFR Parts 803, 806, 807 (Subparts A to D), and 820
Scope of Certification
The certificate covers the production, assembly, sale, distribution, and supply of powered toothbrushes for oral care.
Validity
  • Effective Date: 2024-12-19
  • Expiry Date: 2027-12-18
Verification
The validity of this certificate can be verified by contacting [email protected].
Issued By
IMQ S.p.A., an MDSAP Recognized Auditing Organization, with Matteo Raimondi as the IMQ MDSAP Director.
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Catalog excerpts

MDSAP CERTIFICATE -1

MDSAP CERTIFICATE Certificate No. 008.24-0/MDSAP This is to certify that INDUSTRIA ZINGARDI S.R.L. Via Mazzini 161, 15067 Novi Ligure (AL), Italy Facility ID: F007336 Operates a Quality Management System, which complies with the requirements of ISO 13485:2016 and with the requirements of the following Regulatory Authorities Canada: • Medical Devices Regulations – Part 1- SOR 98/282 United States: • 21 CFR Part 803 • 21 CFR Part 806 • 21 CFR Part 807 - Subparts A to D • 21 CFR Part 820 for the following scope of certification Production, assembly, sale, distribution, and supply of powered toothbrushes for oral care Effective Date: Expiry Date: IMQ Matteo Raimondi – IMQ MDSAP Director IMQ S.p.A. is an MDSAP Recognized Auditing Organization Page 1 of 1 This MDSAP certificate is subjected to the provisions laid down by IMQ in the “Regulation for Conformity Assessment Activities pursuant to Medical Device Single Audit Program (MDSAP) for which IMQ operates as Auditing Organization”. The validity of this certificate can be verified by writing t

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