Illumina Singapore Pte Ltd

Co. Reg. No.: 200310311N

29 Woodlands Industrial Park E1 Northtech Singapore 757716

Tel: 65-6579 2600 Fax: 65-6579 2601

www.illumina.com

Certificate of Conformance

Manufacturer:Illumina, Inc.
Name:ASSY, INSTRUMENT, MISEQ I100 PLUS
Material Number/ Catalog Number:20102513 / 20115695
Serial Number:SH00894
Date of Manufacture:2025-07-07

This document certifies that each instrument conforms to Illumina specifications and is developed and validated following a Certified Quality System, which conforms to ISO 13485 requirements. The integrity of Illumina Quality System is routinely audited and is certified by the British Standards Institute (BSI, Inc.), a quality management system registrar, as meeting the requirements of ISO 13485.

Each instrument goes through the Final Instrument Test with defined acceptance criteria. In accordance with the Device History Record, each instrument must pass the Final Instrument Test and cosmetic and labeling verification, which are performed by qualified and trained manufacturing personnel. The Device History Record is then approved by independent, qualified Quality Assurance personnel.

Verification Details

Verified by:ERWIN COMETA
Title:Quality Operations, Illumina, Inc
Date:18-Aug-2025

Document Information

Document number: 1000000091990 [Version 03]

Printed by: ERWIN COMETA 24-Aug-2025 0:25:23 PST

Page 1 of 1

PDF preview unavailable. Download the PDF instead.

CoC-SH00894 Adobe LiveCycle Designer 11.0 Adobe XML Form Module Library

Related Documents

Preview Illumina MISEQ I100 PLUS Certificate of Conformance
Certificate of Conformance for the Illumina MISEQ I100 PLUS instrument, confirming adherence to Illumina specifications and ISO 13485 quality standards, including details on manufacturing and verification.
Preview Illumina MiSeq i100 Plus Certificate of Conformance - SH00754
Certificate of Conformance for the Illumina MiSeq i100 Plus instrument, serial number SH00754. Details manufacturer, material number, and confirmation of conformity to ISO 13485.
Preview Illumina Certificate of Conformance for MISEQ I100 Instrument
Official Certificate of Conformance for the Illumina MISEQ I100 instrument, confirming adherence to specifications and ISO 13485 quality standards, including details on final testing and authorization.
Preview Illumina MiSeq I100 Certificate of Conformance
Certificate of Conformance for the Illumina MiSeq I100 instrument, detailing adherence to ISO 13485 standards and quality system requirements.
Preview Illumina MISEQ I100 Certificate of Conformance
Certificate of Conformance for Illumina MISEQ I100 instrument, serial number SL00309, confirming adherence to Illumina specifications and ISO 13485 requirements.
Preview Illumina MISEQ I100 Certificate of Conformance - SL00285
Certificate of Conformance for the Illumina MISEQ I100 instrument (Model SL00285), confirming compliance with Illumina specifications and ISO 13485 standards, audited by BSI, Inc.
Preview Illumina MiSeq I100 Certificate of Conformance - SL00293
Certificate of Conformance for Illumina's ASSY, INSTRUMENT, MISEQ I100 (Serial No. SL00293), confirming adherence to ISO 13485 standards and successful final instrument testing.
Preview Illumina MISEQ I100 Certificate of Conformance - SL00303
Certificate of Conformance for Illumina MISEQ I100 instrument (Serial Number: SL00303), confirming adherence to specifications and ISO 13485 standards.