We passed ISO13485 system certificate, and own CE certification for many products.
In terms of quality control, it includs multiple aspects, such as:
1. Regular maintainance of production equipment, as well as good records
2. Annual verification of key equipment
3. The raw material inspection records are classified and archived according to category, semi-finished and finished product inspection records are archived according to product items and batches, and the production records are archived accordingly
4. Purchase: Review and evaluate suppliers, conduct on-site audits when necessary, and sign a quality agreement with the suppliers after passing the audit to clarify the quality responsibilities of both parties
5. Sales: establish product sales records for traceability
6. Carry out management review annually.
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Standard:ISO Number:30418Q00615ROS Issue Date:2020-07-23 Expiry Date:2023-07-22 Scope/Range:Specific protein analyzer and kit(for export only),Hha1c analyzer and kit(for export only),disposable virus sampling tube,nucleic acid extraction or purification reagent ,sample release reagent Issued By:CNCA |
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Standard:CE Number:ECREP20211122.3 Issue Date:2021-11-22 Expiry Date:2024-12-04 Scope/Range:Nucleic Acid Extraction Reagent(magnetic bead method),Flu A & Flu B & COVID-19 Ag Rapid Test,COVID-19 RT - PCR Detection Kit,COVID-19 Ag Rapid Test (Colloidal Gold) Issued By:CMC |
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Standard:CE Number:No.PS-DoC-01,A/0 Issue Date:2020-08-26 Expiry Date:2022-08-26 Scope/Range:Covid-19 RT-PCR Detection Kit Issued By:CMC Medical Devices&Drugs S.L. |
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Standard:CE Number:N.A. Issue Date:2010-08-14 Expiry Date:2017-07-14 Scope/Range:Disposable Viurs Sampling Tube Issued By:EU |
Contact Person: Ms. Carina
Fax: 86-755-89366646
