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RPS_1689_2024_Anotación_10204212062024

RPS_1689_2024_Anotación_10204212062024
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RPS_1689_2024_Anotación_10204212062024

Product catalog summary
Registration Information:
On 12/06/2024, CMC Medical Devices & Drugs S.L. was registered in the Spanish Agency of Medicines and Medical Devices (AEMPS) system for the market placement of medical devices. The registration number is RPS/1689/2024. The company is located at C/ Horacio Lengo, 18, 29006 Málaga, Andalucía, Spain, and acts as a representative.

Compliance:
The company declares compliance with the Directive 98/79/EC.

Products Registered:
  • MgPure Universal Pathogen DNA/RNA Purification Kit: A magnetic beads-based kit for isolating pathogen DNA/RNA from various samples. Manufacturer: Biomiga, Inc., USA.
  • Universal Pathogen DNA/RNA Extraction Kit: A column-based method for isolating pathogen DNA/RNA. Manufacturer: Biomiga, Inc., USA.
  • RPP SC2 FluA&B, RSV A/RSV B 5-Plex real time PCR detection kit: A molecular test for detecting RNA from SARS-CoV-2, influenza A/B, and RSV viruses. Manufacturer: Biomiga, Inc., USA.
  • STI Panel Real Time PCR Detection Kit: Detects 8 pathogens associated with sexually transmitted diseases. Manufacturer: Biomiga, Inc., USA.
  • Gastrointestinal panel real time PCR detection kit: Analyzes stool samples for viral, parasitic, or bacterial nucleic acids. Manufacturer: Biomiga, Inc., USA.
  • Mycoplasma hominis/Mycoplasma genitalium/Ureaplasma urealyticum/Ureaplasma parvum 4-plex real time PCR detection kit: Detects DNA from specific bacteria in urine samples. Manufacturer: Biomiga, Inc., USA.
  • HPV Real Time PCR Detection Kit: Detects HPV nucleic acid types 6 and 11. Manufacturer: Biomiga, Inc., USA.
  • STI trilex, CT/NG/TV, real time PCR detection kit: Detects 3 pathogens associated with sexually transmitted diseases. Manufacturer: Biomiga, Inc., USA.
  • Nail Fungal Real Time PCR detection kit: Detects DNA from bacteria and fungi in nail or skin samples. Manufacturer: Biomiga, Inc., USA.
  • Invasive Fungal Pathogen (IFP) Real Time PCR Assay: Detects 13 pathogens associated with invasive fungal diseases. Manufacturer: Biomiga, Inc., USA.
  • Dengue Virus/Zika Virus/Plasmodium falciparum real time PCR detection kit: For diagnosing dengue and identifying dengue virus serotypes. Manufacturer: Biomiga, Inc., USA.

Note: This notification is not a marketing authorization and does not imply product compliance with current legislation. It confirms compliance with the registration of responsibilities as per article 9 of RD 1662/2000.
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Catalog excerpts

RPS_1689_2024_Anotación_10204212062024-1

DEPARTAMENTO DE PRODUCTOS SANITARIOS CMC Medical Devices & Drugs S.L. C/ Horacio Lengo, 18. Comunicacion: N° AEMPS: Fecha: Anotacion de la comunicacion en el Registro de Responsables de la puesta en el mercado de Productos Sanitarios Con fecha 12/06/2024 ha sido registrada en la aplicacion de Registro de Responsables de la puesta de mercado de Productos Sanitarios (RPS) de la Agencia Espanola de Medicamentos y Productos Sanitarios (AEMPS) la comunicacion presentada por CMC Medical Devices & Drugs S.L., con la siguiente information: 1. Numero de identification asignado en el registro Empresa CMC Medical Devices & Drugs S.L. REGISTRO DE RESPONSABLES DE LA PUESTA EN EL MERCADO DE PRODUCTOS SANITARIOS DEPARTAMENTO DE PRODUCTOS SANITARIOS Nota. - Esta notificacion no tiene el caracter de una autorizacion sanitaria de comercializacion, ni entrana un juicio sobre la conformidad del producto con la legislacion vigente.Unicamente avala el cumplimiento del Registro de Responsables segun el articulo 9 del RD 1662/2000 por el que se regulan los Productos Sanitarios para Diagnostico in vitro.

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RPS_1689_2024_Anotación_10204212062024-2

DEPARTAMENTO DE PRODUCTOS SANITARIOS ANEXO: PRODUCTOS SANITARIOS COMUNICADOS POR EL RESPONSABLE Nombre comercial Fecha de introduccion en el mercado Tipo de producto Finalidad 1 - MgPure Universal Pathogen DNA/RNA Purification Kit, magnetic beads based PARA DIAGNOSTICO "IN VITRO" Autocertificacion 12/06/2024 MgPure Universal Pathogen DNA/RNA Purification Kit provides an easy and reliable method for isolating pathogen DNA/RNA from plasma, serum, nasopharyngeal or oropharyngeal aspirates or washes, nasopharyngeal or oropharyngeal swabs, bronchoalveolar lavage, tracheal aspirates, and sputum. Fabricante...

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RPS_1689_2024_Anotación_10204212062024-3

DEPARTAMENTO DE PRODUCTOS SANITARIOS ANEXO: PRODUCTOS SANITARIOS COMUNICADOS POR EL RESPONSABLE Nombre comercial Fecha de introduccion en el mercado Tipo de producto Finalidad Biomiga, Inc. ESTADOS UNIDOS / UNITED STATES 5 - Gastrointestinal panel real time PCR detection kit PARA DIAGNOSTICO "IN VITRO" Autocertificacion 12/06/2024 The Gastrointestinal Panel Real Time PCR detection kit is a qualitative test intended for analyzing unpreserved stool samples in Cary-Blair transport medium taken from patients suspected of gastrointestinal infection for the presence of viral, parasitic or bacterial...

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RPS_1689_2024_Anotación_10204212062024-4

DEPARTAMENTO DE PRODUCTOS SANITARIOS ANEXO: PRODUCTOS SANITARIOS COMUNICADOS POR EL RESPONSABLE Nombre comercial Fecha de introduccion en el mercado Tipo de producto Finalidad 8 - STI trilex, CT/NG/TV, real time PCR detection kit PARA DIAGNOSTICO "IN VITRO" Autocertificacion 12/06/2024 The STD Panel test is a multiplex PCR test that allows the detection of 3 pathogens associated with sexually transmitted diseases: Chlamydia trachomatis, Trichomonas vaginalis, and Neisseria gonorrhoeae. Fabricante Pais Biomiga, Inc. ESTADOS UNIDOS / UNITED STATES 9 - Nail Funal Real Time PCR detection kit PARA...

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RPS_1689_2024_Anotación_10204212062024-5

DEPARTAMENTO DE PRODUCTOS SANITARIOS ANEXO: PRODUCTOS SANITARIOS COMUNICADOS POR EL RESPONSABLE Nombre comercial Fecha de introduccion en el mercado Tipo de producto Finalidad 11 - Dengue Virus/ Zika Virus/Plasmodium falciparum real time PCR detection kit PARA DIAGNOSTICO "IN VITRO" Autocertificacion The DENV-1-4 Real-Time RT-PCR Assay is intended for use on QuantStudio, BioRad and other standard Real Time PCR instruments. l For the diagnosis of dengue in serum or plasma collected from patients with signs and symptoms consistent with dengue (mild or severe) during the acute phase; l For the identification...

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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.