| Bioteke's Product Qualification Certificate Summaries（by Dec.27th,2021） |
| NO. | Product Name | Product Qualification Certificates (continually updated) |
| 1 | Disposable Virus Sampling Swab Kits | CE Certification –CIBG Registration Letter/ CE Certification–EC Declaration of Conformity/ MHRA Registration/ MHRA Registration- UKCA Declaration of Conformity/ FDA Registration/ CFDA(NMPA) Registration/ Canada MDEL Registration/ Malaysia Registration/ Indonesia Registration/ Italy Registration/ Australian Register of Therapeutic Goods Certificate/ Brazil ANVISA Registration-ST7001/ Botswana registration exemption/ ISO 11737 Test Report/ REACH Test Report/ EN11137 Test Report/ ISO 13485 Certificate/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate |
| 2 | Disposable Sterile Sampling Swab | CE Certification–EC Declaration of Conformity/ BSI EU Quality Management System Certificate/ Test Report/ ISO 13485 Certificate/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate |
| 3 | Nucleic Acid Extraction Kit | CE Certification –CIBG Registration Letter/ CE Certification –EC Declaration of Conformity/ MHRA Registration/ MHRA Registration-UKCA Declaration of Conformity/ FDA Registration/ CFDA(NMPA) Registration/ NQA Compliance Report/ NMPA Registration/ Canada MDEL Registration/ Italy Registration/ Australian Register of Therapeutic Goods Certificate/ Brazil ANVISA Registration-DP46XX/ Brazil ANVISA Registration-AU17011/ EN11737 test report-Prepackaged consumables/ ISO 13485 Certificate/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate |
| 4 | Automated Nucleic Acid Extraction System | CE Certification –CIBG Registration Letter/ CE Certification –EC Declaration of Conformity/ MHRA Registration/ MHRA Registration-UKCA Declaration of Conformity/ NQA Compliance Report/ FDA Registration/ CFDA(NMPA) Registration/ Canada MDEL Registration/ Malaysia Registration/ Indonesia Registration/ Peru Registration exempt/ Italy Registration/ Australian Register of Therapeutic Goods Certificate/ Brazil ANVISA Regsitration/ Saudi Arabia Registration/ Government recommends/ Certificate for Exportation of Medical Products/ Product Test Report-AU1001/ Product Test Report-AU1001-96/ Product Test Report-AU1001S/ ISO 13485 Certificate/ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate |
| 5 | Fast real-time fluorescence PCR analyzer(BTK-8 | CE Certification-IVD Notification Certificate/ CE Certification-E.A.R. Certificate/ CE Certification-Notify body: 2853/ FDA Registration/ Belgium Registration/ Australian Register of Therapeutic Goods Certificate/ Peru Registration exempt/ Italy Registration/ Instrument Test Report/ ISO 13485 Certificate/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate |
| 6 | SARS-CoV-2 Antigen Test Kit(colloidal gold method)/SARS-CoV-2 IgM/IgG Antibody Test Kit(colloidal gold method) | CE Certification –CIBG Registration Letter/ CE Certification –CIBG Registration Prove/ CE Certification –EC Declaration of Conformity/ MHRA Registration/ MHRA Registration- UKCA Declaration of Conformity/ EU COVID-19 In Vitro Diagnostic Devices and Test Methods Database/ Export Qualified Suppliers/ Export Qualified Suppliers (German BfarM
special approval for self-test)/ Bfarm Special approval/ Bfarm List of Antigen-tests of the coronavirus SARS-CoV-2/ PEI tests/ Czech List of antigenic tests for which issued by the ministry exemption/ Austria Registration/ Italy Registration/ Nepal List of approved COVID-19 Antigen Kits/ EU HSC common list/ EU HSC common list/ FIND list of immunoassays and molecular
tests for COVID-19/ Malaysia List of Recommended for Use of Covid-19 IVD Test kit (Professional use only)/ Swiss Lists of rapid tests for SARS-CoV-2 for professional use/ Bulgaria list of rapid antigen test/ France COVID-19 Diagnostic test list - For
nasopharyngeal swab/ Thailand List of Test Kits for COVID-19 -Antigen Rapid Test (Professional Use Only)/ Thailand List of Test Kits for COVID-19 -Antigen Rapid Test (Professional Use Only)/ Bangladesh Emergency Use Authorization
(EUA)/ Indonesia Registration/ Belgium famhp List of the recommended tests/ ISO 13485 Certificate-MDSAP/ ISO 13485 Certificate/ ISO 9001 Certificate/ Free Sale Certificate-Ghana/ ISO 13485 Certificate-MDSAP/ ISO 9001Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate |
| 7 | Freeze-dried Novel Coronavirus (SARS-CoV-2)
Nucleic Acid Detection Kit
(Fluorescence PCR) | CE Certification –CIBG Registration Letter/ CE Certification –EC Declaration of Conformity/ CE Certification –CIBG Website notify/ MHRA Registration/ MHRA Registration-UKCA Declaration of Conformity/ EU Website notify/ Export Qualified Suppliers/ Italy Registration/ Philippines special certification of COVID-19 Diagnostic Kits – PR2019-D/ ISO 13485 Certificate-MDSAP/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate |
| 8 | Novel Coronavirus (SARS-CoV-2)
Nucleic Acid Detection Kit
(Fluorescence PCR) | CE Certification –CIBG Registration Letter/ CE Certification –EC Declaration of Conformity/ EU COVID-19 In Vitro Diagnostic Devices and Test Methods Database/ Export Qualified Suppliers/ Italy Registration/ Bangladesh Emergency Use Authorization
(EUA)/ ISO 13485 Certificate-MDSAP/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate |
| 9 | Hydrogen Peroxide Sterilizer | CE Certification/ EPA Certification/ Test Report-DS1001/ Test Report-DS1000, DS1001, DS1002/ Test Report-DS1001/ Test Report-DS1001 (8% Hydrogen Peroxide)/ Sterilizer Test Report-DS1001 (35% Hydrogen Peroxide)/ Electrical Safety Report/ Health Inspection Institute Registration/ Hygiene License/ ISO 13485 Certificate/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate |
| 10 | Nucleic acid aerosol pollution removal instrument | CE Certification/ Test Report-NC1001/ Test Report/ New product and new technology appraisal and acceptance certificate/Electrical safety report/ Disinfection Products Record/ Hygiene License/ ISO 13485 Certificate-MDSAP/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate |
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