- Customer Information IVDR, (112.3kB)
On May 26, 2022, In Vitro Diagnostics Regulation (IVDR; Regulation (EU) 2017|746) becomes mandatory and replaces the In Vitro Diagnostics Directive (IVDD; Directive 98/79/EC).
- MetaSystems Company Profile, (967.1kB)
- Manuals
- Material Safety Data Sheet (MSDS)
- Instructions for Use (IFU)
- Manufacturer Certificates
- Certificate ISO 13485:2016 and EN ISO 13485:2016 (Instruments), (449.7kB)
- Certificate ISO 13485:2016 (MetaSystems USA), (439.1kB)
- Certificate of Registration: MDSAP, (421.9kB)
- FAQ on CE Mark and ISO Certificate for MetaSystems Imaging Products, (131.0kB)
- Declaration of Conformity Statements (CE)
- Reference Customer Form, (74.4kB)
- Reference Customer Form (Chinese), (186.8kB)
- Certificate: Commitment to Sustainability, (480.3kB)Also available in:
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