Verino Pro Corona SARS-CoV-2 Test Rapido Antigenico User Guide
- June 1, 2024
- Verino Pro
Table of Contents
Verino Pro Corona SARS-CoV-2 Test Rapido Antigenico
Declaration of Conformity
Manufacturer
VivaChek Biotech (Hangzhou) Co., Ltd.
Level 2, Block 2, 146 East Chaofeng Rd, Yuhang Economy Development
Zone,Hangzhou, Zhejiang 311100, China
Tel: +86-571-89182700
Fax: +86-571-89182733
Email: info@vivachek.com
www.vivachek.com
European Representative
Lotus NL B.V.
Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
Tel: +31464168999
E-mail: peter@lotusnl.com
Product Name and Model
| Product name | Specification | REF |
|---|---|---|
| VivaDiag™ Pro SARS-CoV-2 Ag Rapid Test | 1 test | VCD16-10-013 |
| 3 test | VCD16-10-015 | |
| 5 test | VCD16-10-014 | |
| 25 test | VCD16-10-011 | |
| Verino™ Pro SARS-CoV-2 Ag Rapid Test | 1 test | VCD16-10-043 |
| 3 test | VCD16-10-045 | |
| 5 test | VCD16-10-044 | |
| 25 test | VCD16-10-041 |
Classification
Annex III, Section 6, and the Classification/Qualification of medical device is for self-testing.
Conformity assessment procedure: ANNEX III, 98/79/EC
We hereby declare that the above mentioned products meet the COUNCIL DIRECTIVE
98/79/EC and applicable standards. All supporting documentations are retained
in the manufacturer and EU representative.
The declaration is base on the approval by the notify body:
Polskie Centrum Badań i Certyfikacji S.A.ul. Puławska 469 02-844 Warszawa
(PCBC),notified under No.1434 to the EC commission.
The EC certificate No. is 1434-IVDD- 200/2022
Specifications
Directive| DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of
27 October 1998 on in vitro diagnostic medical devices.
---|---
Applicable standards|
- EN ISO 13485:2016
- EN ISO 15223-1:2021
- EN 13612:2002/AC:2002
- EN ISO 18113-1:2011
- EN ISO 18113-4:2011
- EN ISO 23640:2015
- EN 13641:2002
- EN ISO 14971:2019
- EN ISO 17511:2021
- EN 13975:2003
- EN 13532:2002
Place, Date of Issue| Hangzhou, China, Jan 19, 2024
Regulatory Affairs Department| RA Specialist: [Name Redacted]
Attachment1: List of Applicable Harmonised Standards for Rapid Test Self- testing
| No. | Standard Code | Description |
|---|---|---|
| 1 | EN ISO 13485:2016 | Medical devices – Quality management systems – |
Requirements for regulatory purposes
2| EN ISO 15223-1:2021| Medical devices – Symbols to be used with information
to be supplied by the manufacturer – Part 1: General requirements
3| EN 13612:2002/AC:2002| Performance evaluation of in vitro diagnostic
medical devices
4| EN ISO 18113-1:2011| In vitro diagnostic medical devices – Information
supplied by the manufacturer (labelling) – Part 1: Terms, definitions and
general requirements
5
| ****
EN ISO 18113-4:2011
| In vitro diagnostic medical devices – Information supplied by the
manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-
testing
6| EN ISO 23640:2015| In vitro diagnostic medical devices – Evaluation of
stability of in vitro diagnostic reagents
7| EN 13641:2002| Elimination or reduction of risk of infection related to in
vitro diagnostic reagents
8| EN ISO 14971:2019| Medical devices – Application of risk management to
medical devices
9
| ****
EN ISO 17511:2021
| In vitro diagnostic medical devices – Requirements for establishing
metrological traceability of values assigned to calibrators, trueness control
materials and human samples
10| EN 13975:2003| Sampling procedures used for acceptance testing of in vitro
diagnostic medical devices – Statistical aspects
11| EN 13532:2002| General requirements for in vitro diagnostic medical
devices for self-testing
VivaChek Biotech (Hangzhou) Co., Ltd
Level 2, Block 2, 146 East Chaofeng Rd, Yuhang Economy Development Zone,
Hangzhou, Zhejiang 311100, China
Tel: +86-571-89182700 Fax: +86-571-89182733
Email: info@vivachek.com
www.vivachek.com
FAQ
What is the purpose of this document?
This document serves as a Declaration of Conformity indicating that VivaChek Biotech's products meet EU regulatory standards for in vitro diagnostic medical devices.
Where can the supporting documentation for this declaration be found?
The supporting documentation is retained by the manufacturer, VivaChek Biotech, and their EU representative, Lotus NL B.V.
What standards are applicable to VivaChek Biotech's products?
The products adhere to various standards including EN ISO 13485:2016, EN ISO 15223-1:2021, and others listed in the specifications section.
Who approved the products mentioned in this declaration?
The products were approved by Polskie Centrum Badań i Certyfikacji S.A., as notified to the EC commission under No.1434.
How can I contact the manufacturer or the European representative for more information?.
Contact details for the manufacturer and European representative are provided in the respective sections above.
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