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CERT-Biomiga,Inc.-4651-ECREP20240612.1

CERT-Biomiga,Inc.-4651-ECREP20240612.1
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CERT-Biomiga,Inc.-4651-ECREP20240612.1

Product catalog summary

Certificate Overview: This document certifies that CMC Medical Devices & Drugs S.L. is the European Authorized Representative for Biomiga, Inc., located in San Diego, United States. The certificate is valid until November 14, 2024, contingent upon positive results from periodic surveillance audits and compliance with EU legislation.

Validity Conditions: The certificate remains valid unless there are changes in manufacturing conditions, the quality system, or relevant legislation. The manufacturer is responsible for product liability as per applicable directives and regulations.

CE Marking: After meeting EU legislation requirements, the manufacturer must affix the CE marking to the relevant medical device models listed in Annex I.

Registration: Products listed in Annex I are registered with the Spanish Ministry of Health (AEMPS), with registration numbers provided in the RPS column.

Annex I - Product List:

  • Universal Pathogen DNA/RNA Extraction Kit, mini column based
  • STI trilex, CT/NG/TV, real time PCR detection kit
  • STI Panel Real Time PCR Detection Kit
  • RPP SC2 FluA&B, RSV A/RSV B 5-Plex real time PCR detection kit
  • Nail Fungal Real Time PCR detection kit
  • Mycoplasma hominis/Mycoplasma genitalium/Ureaplasma urealyticum/Ureaplasma parvum serovar 4-plex real time PCR detection kit
  • MgPure Universal Pathogen DNA/RNA Purification Kit, magnetic beads based
  • Invasive Fungal Pathogen (IFP) Real Time PCR Assay
  • HPV Real Time PCR Detection Kit
  • Gastrointestinal panel real time PCR detection kit
  • Dengue Virus/Zika Virus/Plasmodium falciparum real time PCR detection kit

All products are classified under the IVDD-Directive 98/79 and are registered with AEMPS under the registration number RPS/1689/2024.

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Catalog excerpts

CERT-Biomiga,Inc.-4651-ECREP20240612.1-1

CMC MEDICAL DEVICES & DRUGS S.L. CONFIRMED THAT CMC MEDICAL DEVICES & DRUGS S.L. Is the European Authorized Representative of Biomiga,Inc. 10637 Roselle St Ste C, 92121, San Diego, United States The certificate remains valid until the expiration date of the EC REP agreement, or until manufacturing conditions, quality system or relevant legislation are modified. The validity is subject to positive results of periodic surveillance audits. The product liability rests with the manufacturer in accordance with applicable directive/regulation mentioned in Annex I of this certificate and the applicable standards. After fulfilling the relevant EU legislation requirements, the manufacturer shall affix the appropriate CE marking to the relevant models of the medical devices mentioned below. These products included in the Annex I have been registered in the Spanish MOH (AEMPS) if applicable. In this case, the column categorized as RPS reffers to their registration number. Authorized Signature Issue date: 12/06/2024 CMC Medical Devices & Drugs S.L. C/ Horacio Lengo Nº18, CP29006, Málaga-Spain www.cmcmedicaldevices.com Expiration date: 14/11/2024 Verification code

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CERT-Biomiga,Inc.-4651-ECREP20240612.1-2

ANNEX I Product Name Issue date: 12/06/2024 CMC Medical Devices & Drugs S.L. C/ Horacio Lengo N°18, CP29006, Malaga-Spain www.cmcmedicaldevices.com Expiration date: 14/11/2024 Verification code

 Open the catalog to page 2

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.