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РУ № РЗН 2019/9316 от 02 декабря 2019 года

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  • РУ Росздравнадзора № РЗН 2019/9316 от 02 декабря 2019 года
Номер РУ РЗН 2019/9316
Класс опасности 2а (медизделия со средней степенью риска)
Код ОКП/ОКПД2 32.50.11.000
Дата выдачи РУ 02 декабря 2019 года
Дата окончания РУ Действует бессрочно
Вид медицинского изделия
299930
Номер записи в реестре 37267
Наименование медицинского изделия Заготовки из диоксида циркония для стоматологической реставрации серии DentalDirekt (DD) На медицинское изделие Заготовки из диоксида циркония для стоматологической реставрации серии DentalDirekt (DD), в вариантах исполнения: 1. DDBioZW iso: DD Bio ZW iso 98H10 white, DD Bio ZW iso 98HI2 white, DD Bio ZW iso 98HI4 white, DD Bio ZW iso 98H16 white, DD Bio ZW iso 98H18 white, DD Bio ZW iso 98H20 white, DD Bio ZW iso 98H25 white. 2. DD Bio ZW iso color: DD Bio ZW iso 98HI0 500, DD Bio ZW iso 98H14 500, DD BioZW iso98H18 500, DD Bio ZW iso 98ti20 500, DD Bio ZW iso 98H25 500, DD Bio ZW iso 98H10 800, DD Bio ZW iso 98H14 800, DD Bio ZW iso 98И18 800, DD Bio ZW iso 98H20 800, DD Bio ZW iso 98H25 800, DD Bio ZW iso 98И10 1000, DD Bio ZW iso 98H14 1000, DD Bio ZW iso 98H18 1000, DD Bio ZW iso 981120 1000, DD Bio ZW iso 98H25 1000, DD Bio ZW iso 98H10 1333, DD Bio ZW iso 98H14 1333, DD Bio ZW iso 98H18 1333, DD Bio ZW iso 98H20 1333, DD Bio ZW iso 98H25 1333, DD Bio ZW iso 981110 2000, DD Bio ZW iso 98H14 2000, DD Bio ZW iso 981118 2000, DD Bio ZW iso 98И20 2000, DD Bio ZW iso 98H25 2000. 3. DD Bio ZA: DD Bio ZA 71H12 white, DD Bio ZA 71H14 white, DD Bio ZA 71H16 white, DD Bio ZA 71H18 white. DD Bio ZA 71H20 white, DD Bio ZA 71M25 white. 4. DD Bio ZS: DD Bio ZS 20/19 white, DD Bio ZS 21/15 white, DD Bio ZS 40/15 white, DD Bio ZS 40/19 white, DD Bio ZS 55/19 InLab white, DD Bio ZS 55/19 MCXL white, DD Bio ZS 65/25 white, DD Bio ZS 85/40 white. 5. DD Bio ZX298: DD Bio ZX2 981110 white, DD Bio ZX2 98H12 white, DD Bio ZX2 98H14 white, DD Bio ZX2 98H16 white, DD Bio ZX2 981118 white, DD Bio ZX2 98H20 white, DD Bio ZX2 98H25 white, DD Bio ZX2 98Н14 /ohne Stufe white, DD Bio ZX2 98H18 / ohne Stufe white, DD Bio ZX2 98H20 / ohne Stufe white, DD Bio ZX2 98H25/ ohne Stufe white. 6. DD Bio ZX2 98 color: DD Bio ZX2 98H10 Light, DD Bio ZX2 98H14 Light, DD Bio ZX2 98H18 Light, DD Bio ZX2 98H20 Light, DD Bio ZX2 98H25 Light, DD Bio ZX2 98H10 Medium, DD Bio ZX2 98H14 Medium, DD Bio ZX2 98H18 Medium, DD Bio ZX2 98H20 Medium, DD Bio ZX2 981125 Medium, DD Bio ZX2 98H10 Intense, DD Bio ZX2 981110 Intense. DD Bio ZX2 98H14 Intense, DD Bio ZX2 98H18 Intense, DD Bio ZX2 98H20 Intense, DD Bio ZX2 98H25 Intense, DD Bio ZX2 98H10 Low chromatic, DD Bio ZX2 98H14 Low chromatic, DD Bio ZX2 98H18 Low chromatic, DD Bio ZX2 98H20 Low chromatic, DD Bio ZX2 98H25 Low chromatic, DD Bio ZX2 98H10 High chromatic, DD Bio ZX2 98H14 High chromatic, DD Bio ZX2 98Н8 High chromatic, DD Bio ZX2 98H20 High chromatic, DD Bio ZX2 98H25 High chromatic, DD Bio ZX2 98H10 A1, DD Bio ZX2 98H14 Al, DD Bio ZX2 98H18 A1, DD Bio ZX2 98H20 Al, DD Bio ZX2 98H25 Al, DD Bio ZX2 98H10 A2, DD Bio ZX2 98HI4 A2, DD Bio ZX2 98H18 A2, DD Bio ZX2 98H20 A2, DD Bio ZX2 98H25 A2, DD Bio ZX2 98H10 A3, DD Bio ZX2 98H14 A3, DD Bio ZX2 98H18 A3, DD Bio ZX2 98H20 A3, DD Bio ZX2 98H25 A3, DD Bio ZX2 98H10 A3.5, DD Bio ZX2 98H14 A3.5, DD Bio ZX2 98H18 A3.5, DD Bio ZX2 981120 A3.5, DD Bio ZX2 98H25 A3.5, DD Bio ZX2 98HI0 A4, DD Bio ZX2 98H14 A4, DD Bio ZX2 98H18 A4, DD Bio ZX2 98H20 A4, DD Bio ZX2 98H25 A4, DD Bio ZX2 98H10 Bl, DD Bio ZX2 98H14 Bl, DD Bio ZX2 98H18 Bl, DD Bio ZX2 98H20 Bl, DD Bio ZX2 98I125 Bl, DD Bio ZX2 98H10 B2, DD Bio ZX2 98H14 B2, DD Bio ZX2 98H18 B2, DD Bio ZX2 98H20 B2, DD Bio ZX2 98H25 B2, DD Bio ZX2 98H10 B3, DD Bio ZX2 98H14 B3, DD Bio ZX2 98H18 B3, DD Bio ZX2 98H20 B3, DD Bio ZX2 98H25 B3, DD Bio ZX2 98H10 B4, DD Bio ZX2 98H14 B4, DD Bio ZX2 98H18 B4, DD Bio ZX2 98H20 B4, DD Bio ZX2 98H25 B4, DD Bio ZX2 98H10 CL, DD Bio ZX2 98H14 Cl, DD Bio ZX2 98H18 Cl, DD Bio ZX2 98H20 C l, DD Bio ZX2 98H25 Cl, DD Bio ZX2 98H10 C2, DD Bio ZX2 98H14 C2, DD Bio ZX2 98H18 C2, DD Bio ZX2 98H20 C2, DD Bio ZX2 98H25 C2, DO Bio ZX2 98HI0 C3, DD Bio ZX2 98HI4 C3, DD Bio ZX2 98H18 C3, DD Bio ZX2 98H20 C3, DD Bio ZX2 C3, DD Bio ZX2 98H10 C4, DD Bio ZX2 98H14 C4, DD Bio ZX2 98H18 C4, DD Bio ZX2 98H20 C4, DD Bio ZX2 98H25 C4, DD Bio ZX2 98HI0 D2, DD Bio ZX2 98H14 D2, DD Bio ZX2 98H8 D2, DD Bio ZX2 98H20 D2, DD Bio ZX2 98H25 D2, DD Bio ZX2 98H10 D3, DD Bio ZX2 98H14 D3, DD Bio ZX2 98H18 D3, DD Bio ZX2 98H20 D3, DD Bio ZX2 98H25 D3, DD Bio ZX2 98H10 D4, DD Bio ZX2 98H14 D4, DD Bio ZX2 98H18 D4, DD Bio ZX2 98H20 D4, DD Bio ZX2 98H25 D4. 7. DD Bio ZX2 7l: DD Bio ZX2 71HI2 white, DD Bio ZX2 71HI4 white, DD Bio ZX2 71H16 white, DD Bio ZX2 71H18 white, DD Bio ZX2 71H20 white, DD Bio ZX2 71H25 white. 8. DD Bio ZX2 100: DD Bio ZX2 l00H10 white, DD Bio ZX2 100H12 white, DD Bio ZX2 100H14 white, DD Bio ZX2 100H16 white, DD Bio ZX2 100Н18 white, DD Bio ZX2 100H20 white, DD Bio ZX2 100H25 white. 9. DD Bio ZX2 95: DD Bio ZX2 95H10 white, DD Bio ZX2 95H14 white, DD Bio ZX2 95H18 white, DD Bio ZX2 95H22 white, DD Bio ZX2 95H25 white. 10. DD Bio ZX2 19: DD Bio ZX2 20/19 white, DD Bio ZX2 40/19 white, DD Bio ZX2 55/19 MCXL white, DD Bio ZX2 65/25 white. 11. DD cubeX2 98: DD cubeX2 98H10 white, DD cubeX2 98HI2 white, DD cubeX2 98H14 white, DD cubeX2 98HI6 white, DD cubeX2 98H18 white, DD cubeX2 98H20 white, DD cubeX2 98H25 white. 12. DD cubeX2 ML 9 8 : DD cubeX2 ML 98H14 Al, DD cubeX2 ML 98H18 A1, DD cubeX2 ML 98H22 A1, DD cubeX2 ML 98H14 A2, DD cubeX2 ML 98H18 A2, DD cubeX2 ML 98H22 A2, DD cubeX2 ML 98H14 A3, DD cubeX2 ML 98H18 A3, DD cubcX2 ML 98H22 A3, DD cubeX2 ML 98H14 A3.5, DD cubeX2 ML 98HI8 A3.5, DD cubeX2 ML 98H22 A3.5, DD cubeX2 ML 98H14 B2, DD cubeX2 ML 98HI8 B2, DD cubeX2 ML 98H22 B2, DD cubeX2 ML 98H14 C2, DD cubeX2 ML 98H18 C2, DD cubeX2 ML 98H22 C2, DD eubeX2 ML 98H14 D3, DD cubeX2 ML 98HI8 D3, DD cubeX2 ML 98H22 D3. 13. DD cubeX2 95: DD cubeX2 95H10 white, DD cubeX2 95HI4 white, DD cubeX2 95H18 white, DD cubeX2 95H22 white, DD cubeX2 95H25 white. 14. DD cube ONE 98: DD cube ONE 98H10 white, DD cube ONE 98HI4 white, DD cube ONE 98H18 white, DD cube ONE 98H20 white, DD cube ONE 98H25 white.
Заявитель (держатель РУ) ООО «Артикон»
Фактический адрес заявителя 195027, Россия, г. Санкт-Петербург, ул. Магнитогорская, д. 51, лит. Р, пом. 1-Н
Юридический адрес заявителя 195027, Россия, г. Санкт-Петербург, ул. Магнитогорская, д. 51, лит. Р, пом. 1-Н
Изготовитель Дентал Директ ГмбХ
Фактический адрес изготовителя Германия, Dental Direkt GmbH, Industriezentrum 106-108, D-32139 Spenge, Germany
Юридический адрес изготовителя Германия, Дальнее зарубежье, Dental Direkt GmbH, Industriezentrum 106-108, D-32139 Spenge, Germany
Производственная площадка Dental Direkt GmbH, St. Annener Str. 119, 49326 Melle, Germany
Информация о регистрации медицинских изделий здесь.