EC Type-Examination Certificate EC Type-Examination Certificate
EC Type-Examination Certificate Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD), Annex V Supplementary Information to CE 643322 Issued To: No. Issued To:
Omixon Biocomputing Ltd CE 643322 Fehérvári út 50-52 Omixon Biocomputing Ltd Budapest Fehérvári 1117 út 50-52 Hungary Budapest
1117 Hungary
In respect of:
Holotype HLA
on the basis of our examination under the requirements of Council Directive 98/79/EC, Annex V, the type conforms to the relevant provision of 98/79/EC.
For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 0086):
Frank Lee, EMEA Compliance & Risk Director First First Issued: Issued: 24 24 March March 2016 2016
Date: Date: 24 24 March March 2016 2016
Expiry Expiry Date: Date: 23 23 March March 2021 2021
Page 1 of 3 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.
EC Type-Examination Certificate Supplementary Information to CE 643322 Issued To:
Omixon Biocomputing Ltd Fehérvári út 50-52 Budapest 1117 Hungary
Products: Holotype HLA 24/7 - Configuration A1 & CE (REF H52) Holotype HLA 96/7 - Configuration A & CE (REF H32)
First Issued: 24 March 2016
Date: 24 March 2016
Expiry Date: 23 March 2021
Page 2 of 3 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.
EC Type-Examination Certificate Supplementary Information to CE 643322 Issued To:
Omixon Biocomputing Ltd Fehérvári út 50-52 Budapest 1117 Hungary
Certificate History Date 24 March 2016
First Issued: 24 March 2016
Reference Number 10158746
Action First Issue
Date: 24 March 2016
Expiry Date: 23 March 2021
Page 3 of 3 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.
Omixon Biocomputing Ltd CE 643322 Fehérvári út 50-52 Omixon Biocomputing Ltd Budapest Fehérvári 1117 út 50-52 Hungary Budapest
1117 Hungary
In respect of:
Holotype HLA
on the basis of our examination under the requirements of Council Directive 98/79/EC, Annex V, the type conforms to the relevant provision of 98/79/EC.
For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 0086):
Frank Lee, EMEA Compliance & Risk Director First First Issued: Issued: 24 24 March March 2016 2016
Date: Date: 24 24 March March 2016 2016
Expiry Expiry Date: Date: 23 23 March March 2021 2021
Page 1 of 3 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.
EC Type-Examination Certificate Supplementary Information to CE 643322 Issued To:
Omixon Biocomputing Ltd Fehérvári út 50-52 Budapest 1117 Hungary
Products: Holotype HLA 24/7 - Configuration A1 & CE (REF H52) Holotype HLA 96/7 - Configuration A & CE (REF H32)
First Issued: 24 March 2016
Date: 24 March 2016
Expiry Date: 23 March 2021
Page 2 of 3 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.
EC Type-Examination Certificate Supplementary Information to CE 643322 Issued To:
Omixon Biocomputing Ltd Fehérvári út 50-52 Budapest 1117 Hungary
Certificate History Date 24 March 2016
First Issued: 24 March 2016
Reference Number 10158746
Action First Issue
Date: 24 March 2016
Expiry Date: 23 March 2021
Page 3 of 3 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000 BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK. A member of BSI Group of Companies.
