Potential risk:
All risks- All risks
- Active implantable medical devices
- Class b
- Class І
- Class ІІ a
- Class ІІІ
- In vitro diagnostic devices
- IVD others
- Reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies
- Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell
- Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd
- Reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B
- Reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia
- Reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA
- Reagents and reagent products, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria
- Reagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis
- Reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTL
- Self-testing devices other than indicated in B9
- The following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar
- Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation
- Клас B (Регламент (ЕС) 2017/746)
- Клас C (Регламент (ЕС) 2017/746)
- Клас D (Регламент (ЕС) 2017/746)
- КЛАС А Нестерилни (Регламент (ЕС) 2017/746)
- Клас А стерилни (Регламент (ЕС) 2017/746)
- медицински изделия от клас I по поръчка
- медицински изделия от клас I с измерващи функции
- медицински изделия от клас III по поръчка
- Оreagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21
- стерилни медицински изделия от клас I
- хирургически инструменти за многократна употреба
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