Параметр изделия | Значение параметра |
Регистрационный номер | РЗН 2016/3896 |
Дата государственной регистрации | 04.04.2016 |
Срок действия регистрационного удостоверения | |
Наименование медицинского изделия | Материалы для изготовления безметалловых ортопедических конструкций IPSВарианты исполнения:I.Блоки из стеклокерамики IPS e.max CAD, варианты исполнения:1.IPS e.max CAD for CEREC and inLab MO 2 / A14 (S).2.IPS e.max CAD for Milling Center MO 0 / C14.3.IPS e.max CAD for Milling Center MO 1 / C14.4.IPS e.max CAD for Milling Center MO 2 / C14.5.IPS e.max CAD for Milling Center MO 3 / C14.6.IPS e.max CAD for Milling Center MO 4 / C14.7.IPS e.max CAD for Milling Center LT BL2 / C16.8.IPS e.max CAD for Milling Center LT A1 / C16.9.IPS e.max CAD for Milling Center LT A2 / C16.10.IPS e.max CAD for Milling Center LT A3 / C16.11.IPS e.max CAD for Milling Center LT A3,5 / C16.12.IPS e.max CAD for Milling Center LT B1 / C16.13.IPS e.max CAD for Milling Center LT B2 / C16.14.IPS e.max CAD for Milling Center LT C1 / C16.15.IPS e.max CAD for Milling Center LT C2 / C16.16.IPS e.max CAD for Milling Center LT D2 / C16.17.IPS e.max CAD for CEREC and inLab HT A1 / B40L.18.IPS e.max CAD for CEREC and inLab HT A2 / B40L.19.IPS e.max CAD for CEREC and inLab HT A3 / B40L.20.IPS e.max CAD for CEREC and inLab HT A3,5 / B40L.21.IPS e.max CAD for CEREC and inLab HT A4 / B40L.22.IPS e.max CAD for CEREC and inLab HT B1 / B40L.23.IPS e.max CAD for CEREC and inLab HT B2 / B40L.24.IPS e.max CAD for CEREC and inLab HT B3 / B40L.25.IPS e.max CAD for CEREC and inLab HT B4 / B40L.26.IPS e.max CAD for CEREC and inLab HT C1 / B40L.27.IPS e.max CAD for CEREC and inLab HT C2 / B40L.28.IPS e.max CAD for CEREC and inLab HT C3 / B40L.29.IPS e.max CAD for CEREC and inLab HT C4 / B40L.30.IPS e.max CAD for CEREC and inLab HT D2 / B40L.31.IPS e.max CAD for CEREC and inLab HT D3 / B40L.32.IPS e.max CAD for CEREC and inLab HT D4 / B40L.33.IPS e.max CAD for CEREC and inLab HT BL1 / B40L.34.IPS e.max CAD for CEREC and inLab HT BL2 / B40L.35.IPS e.max CAD for CEREC and inLab HT BL3 / B40L.36.IPS e.max CAD for CEREC and inLab HT BL4 / B40L.37.IPS e.max CAD for E4D LT A1 / I12.38.IPS e.max CAD for E4D LT A2 / I12.39.IPS e.max CAD for E4D LT A3 / I12.40.IPS e.max CAD for E4D LT A3,5 / I12.41.IPS e.max CAD for E4D LT B1 / I12.42.IPS e.max CAD for E4D LT B2 / I12.43.IPS e.max CAD for E4D LT B3 / I12.44.IPS e.max CAD for E4D LT C2 / I12.45.IPS e.max CAD for E4D LT D3 / I12.46.IPS e.max CAD for E4D LT A1 / C14.47.IPS e.max CAD for E4D LT A2 / C14.48.IPS e.max CAD for E4D LT A3 / C14.49.IPS e.max CAD for E4D LT A3,5 / C14.50.IPS e.max CAD for E4D LT B1 / C14.51.IPS e.max CAD for E4D LT B2 / C14.52.IPS e.max CAD for E4D LT B3 / C14.53.IPS e.max CAD for E4D LT C2 / C14.54.IPS e.max CAD for E4D LT D3 / C14.55.IPS e.max CAD for E4D LT BL1 / I12.56.IPS e.max CAD for E4D LT BL2 / I12.57.IPS e.max CAD for E4D LT BL3 / I12.58.IPS e.max CAD for E4D LT BL4 / I12.59.IPS e.max CAD for E4D LT BL1 / C14.60.IPS e.max CAD for E4D LT BL2 / C14.61.IPS e.max CAD for E4D LT BL3 / C14.62.IPS e.max CAD for E4D LT BL4 / C14.63.IPS e.max CAD for E4D LT A4 / I12.64.IPS e.max CAD for E4D LT B4 / I12.65.IPS e.max CAD for E4D LT C1 / I12.66.IPS e.max CAD for E4D LT C3 / I12.67.IPS e.max CAD for E4D LT C4 / I12.68.IPS e.max CAD for E4D LT D2 / I12.69.IPS e.max CAD for E4D LT C3 / I14.70.IPS e.max CAD for E4D LT C4 / I14.71.IPS e.max CAD for E4D LT D2 / I14.72.IPS e.max CAD for E4D LT D4 / I14.73.IPS e.max CAD for E4D HT A1 / I12.74.IPS e.max CAD for E4D HT A2 / I12.75.IPS e.max CAD for E4D HT A3 / I12.76.IPS e.max CAD for E4D HT A3,5 / I12.77.IPS e.max CAD for E4D HT A4 / I12.78.IPS e.max CAD for E4D HT B1 / I12.79.IPS e.max CAD for E4D HT B2 / I12.80.IPS e.max CAD for E4D HT B3 / I12.81.IPS e.max CAD for E4D HT B4 / I12.82.IPS e.max CAD for E4D HT C1 / I12.83.IPS e.max CAD for E4D HT C2 / I12.84.IPS e.max CAD for E4D HT C3 / I12.85.IPS e.max CAD for E4D HT C4 / I12.86.IPS e.max CAD for E4D HT D2 / I12.87.IPS e.max CAD for E4D HT D3 / I12.88.IPS e.max CAD for E4D HT D4 / I12.89.IPS e.max CAD for E4D HT A1 / C14.90.IPS e.max CAD for E4D HT A2 / C14.91.IPS e.max CAD for E4D HT A3 / C14.92.IPS e.max CAD for E4D HT A3,5 / C14.93.IPS e.max CAD for E4D HT A4 / C14.94.IPS e.max CAD for E4D HT B1 / C14.95.IPS e.max CAD for E4D HT B2 / C14.96.IPS e.max CAD for E4D HT B3 / C14.97.IPS e.max CAD for E4D HT B4 / C14.98.IPS e.max CAD for E4D HT C1 / C14.99.IPS e.max CAD for E4D HT C2 / C14.100.IPS e.max CAD for E4D HT C3 / C14.101.IPS e.max CAD for E4D HT C4 / C14.102.IPS e.max CAD for E4D HT D2 / C14.103.IPS e.max CAD for E4D HT D3 / C14.104.IPS e.max CAD for E4D HT D4 / C14.105.IPS e.max CAD for E4D HT BL1 / I12.106.IPS e.max CAD for E4D HT BL2 / I12.107.IPS e.max CAD for E4D HT BL3 / I12.108.IPS e.max CAD for E4D HT BL4 / I12.109.IPS e.max CAD for E4D HT BL1 / C14.110.IPS e.max CAD for E4D HT BL2 / C14.111.IPS e.max CAD for E4D HT BL3 / C14.112.IPS e.max CAD for E4D HT BL4 / C14.113.IPS e.max CAD for E4D Impulse O1 / C14.114.IPS e.max CAD for E4D Impulse O2 / C14.115.IPS e.max CAD for E4D Impulse V1 / C14.116.IPS e.max CAD for E4D Impulse V2 / C14.117.IPS e.max CAD for E4D Impulse V3 / C14.118.IPS e.max CAD for E4D LT A1 / C16.119.IPS e.max CAD for E4D LT A2 / C16.120.IPS e.max CAD for E4D LT A3 / C16.121.IPS e.max CAD for E4D LT A3,5 / C16.122.IPS e.max CAD for E4D LT B1 / C16.123.IPS e.max CAD for E4D LT B2 / C16.124.IPS e.max CAD for E4D LT C1 / C16.125.IPS e.max CAD for E4D LT C2 / C16.126.IPS e.max CAD for E4D LT D2 / C16.127.IPS e.max CAD for E4D LT A1 / B32.128.IPS e.max CAD for E4D LT A2 / B32.129.IPS e.max CAD for E4D LT A3 / B32.130.IPS e.max CAD for E4D LT A3,5 / B32.131.IPS e.max CAD for E4D LT B1 / B32.132.IPS e.max CAD for E4D LT B2 / B32.133.IPS e.max CAD for E4D LT C1 / B32.134.IPS e.max CAD for E4D LT C2 / B32.135.IPS e.max CAD for E4D LT D2 / B32.136.IPS e.max CAD for E4D LT BL2 / C16.137.IPS e.max CAD for E4D LT BL2 / B32.138.IPS e.max CAD for Milling Center LT A1 / C14.139.IPS e.max CAD for Milling Center LT A2 / C14.140.IPS e.max CAD for Milling Center LT A3 / C14.141.IPS e.max CAD for Milling Center LT A3,5 / C14.142.IPS e.max CAD for Milling Center LT A4 / C14.143.IPS e.max CAD for Milling Center LT B1 / C14.144.IPS e.max CAD for Milling Center LT B2 / C14.145.IPS e.max CAD for Milling Center LT B3 / C14.146.IPS e.max CAD for Milling Center LT B4 / C14.147.IPS e.max CAD for Milling Center LT C1 / C14.148.IPS e.max CAD for Milling Center LT C2 / C14.149.IPS e.max CAD for Milling Center LT C3 / C14.150.IPS e.max CAD for Milling Center LT C4 / C14.151.IPS e.max CAD for Milling Center LT D2 / C14.152.IPS e.max CAD for Milling Center LT D3 / C14.153.IPS e.max CAD for Milling Center LT D4 / C14.154.IPS e.max CAD for Milling Center LT BL1 / C14.155.IPS e.max CAD for Milling Center LT BL2 / C14.156.IPS e.max CAD for Milling Center LT BL3 / C14.157.IPS e.max CAD for Milling Center LT BL4 / C14.158.IPS e.max CAD for Milling Center HT A1 / C14.159.IPS e.max CAD for Milling Center HT A2 / C14.160.IPS e.max CAD for Milling Center HT A3 / C14.161.IPS e.max CAD for Milling Center HT A3,5 / C14.162.IPS e.max CAD for Milling Center HT A4 / C14.163.IPS e.max CAD for Milling Center HT B1 / C14.164.IPS e.max CAD for Milling Center HT B2 / C14.165.IPS e.max CAD for Milling Center HT B3 / C14.166.IPS e.max CAD for Milling Center HT B4 / C14.167.IPS e.max CAD for Milling Center HT C1 / C14.168.IPS e.max CAD for Milling Center HT C2 / C14.169.IPS e.max CAD for Milling Center HT C3 / C14.170.IPS e.max CAD for Milling Center HT C4 / C14.171.IPS e.max CAD for Milling Center HT D2 / C14.172.IPS e.max CAD for Milling Center HT D3 / C14.173.IPS e.max CAD for Milling Center HT D4 / C14.174.IPS e.max CAD for Milling Center HT BL1 / C14.175.IPS e.max CAD for Milling Center HT BL2 / C14.176.IPS e.max CAD for Milling Center HT BL3 / C14.177.IPS e.max CAD for Milling Center HT BL4 / C14178.IPS e.max CAD for Milling Center LT A1 / B32.179.IPS e.max CAD for Milling Center LT A2 / B32.180.IPS e.max CAD for Milling Center LT A3 / B32.181.IPS e.max CAD for Milling Center LT A3,5 / B32.182.IPS e.max CAD for Milling Center LT B1 / B32.183.IPS e.max CAD for Milling Center LT B2 / B32.184.IPS e.max CAD for Milling Center LT C1 / B32.185.IPS e.max CAD for Milling Center LT C2 / B32.186.IPS e.max CAD for Milling Center LT D2 / B32.187.IPS e.max CAD for Milling Center LT BL2 / B32.188.IPS e.max CAD for Milling Center HT A1 / B40L.189.IPS e.max CAD for Milling Center HT A2 / B40L.190.IPS e.max CAD for Milling Center HT A3 / B40L.191.IPS e.max CAD for Milling Center HT A3,5 / B40L.192.IPS e.max CAD for Milling Center HT B1 / B40L.193.IPS e.max CAD for Milling Center HT B2 / B40L.194.IPS e.max CAD for Milling Center HT C1 / B40L.195.IPS e.max CAD for Milling Center HT C2 / B40L.196.IPS e.max CAD for Milling Center HT D2 / B40L.197.IPS e.max CAD for Milling Center HT BL / B40L.198.IPS e.max CAD for PlanMill Impulse O1 / C14.199.IPS e.max CAD for PlanMill Impulse O2 / C14.200.IPS e.max CAD for PlanMill Impulse V1 / C14.201.IPS e.max CAD for PlanMill Impulse V2 / C14.202.IPS e.max CAD for PlanMill Impulse V3 / C14.203.IPS e.max CAD for PlanMill LT A1 / I12.204.IPS e.max CAD for PlanMill LT A2 / I12.205.IPS e.max CAD for PlanMill LT A3 / I12.206.IPS e.max CAD for PlanMill LT A3,5 / I12.207.IPS e.max CAD for PlanMill LT A4 / I12.208.IPS e.max CAD for PlanMill LT B1 / I12.209.IPS e.max CAD for PlanMill LT B2 / I12.210.IPS e.max CAD for PlanMill LT B3 / I12.211.IPS e.max CAD for PlanMill LT B4 / I12.212.IPS e.max CAD for PlanMill LT C1 / I12.213.IPS e.max CAD for PlanMill LT C2 / I12.214.IPS e.max CAD for PlanMill LT C3 / I12.215.IPS e.max CAD for PlanMill LT C4 / I12.216.IPS e.max CAD for PlanMill LT D2 / I12.217.IPS e.max CAD for PlanMill LT D3 / I12.218.IPS e.max CAD for PlanMill LT D4 / I12.219.IPS e.max CAD for PlanMill LT A1 / C14.220.IPS e.max CAD for PlanMill LT A2 / C14.221.IPS e.max CAD for PlanMill LT A3 / C14.222.IPS e.max CAD for PlanMill LT A3,5 / C14.223.IPS e.max CAD for PlanMill LT A4 / C14.224.IPS e.max CAD for PlanMill LT B1 / C14.225.IPS e.max CAD for PlanMill LT B2 / C14.226.IPS e.max CAD for PlanMill LT B3 / C14.227.IPS e.max CAD for PlanMill LT B4 / C14.228.IPS e.max CAD for PlanMill LT C1 / C14.229.IPS e.max CAD for PlanMill LT C2 / C14.230.IPS e.max CAD for PlanMill LT C3 / C14.231.IPS e.max CAD for PlanMill LT C4 / C14.232.IPS e.max CAD for PlanMill LT D2 / C14.233.IPS e.max CAD for PlanMill LT D3 / C14.234.IPS e.max CAD for PlanMill LT D4 / C14.235.IPS e.max CAD for PlanMill LT A1 / C16.236.IPS e.max CAD for PlanMill LT A2 / C16.237.IPS e.max CAD for PlanMill LT A3 / C16.238.IPS e.max CAD for PlanMill LT A3,5 / C16.239.IPS e.max CAD for PlanMill LT A4 / C16.240.IPS e.max CAD for PlanMill LT B1 / C16.241.IPS e.max CAD for PlanMill LT B2 / C16.242.IPS e.max CAD for PlanMill LT B3 / C16.243.IPS e.max CAD for PlanMill LT B4 / C16.244.IPS e.max CAD for PlanMill LT C1 / C16.245.IPS e.max CAD for PlanMill LT C2 / C16.246.IPS e.max CAD for PlanMill LT C3 / C16.247.IPS e.max CAD for PlanMill LT C4 / C16.248.IPS e.max CAD for PlanMill LT D2 / C16.249.IPS e.max CAD for PlanMill LT D3 / C16.250.IPS e.max CAD for PlanMill LT D4 / C16.251.IPS e.max CAD for PlanMill LT A1 / B32.252.IPS e.max CAD for PlanMill LT A2 / B32.253.IPS e.max CAD for PlanMill LT A3 / B32.254.IPS e.max CAD for PlanMill LT A3,5 / B32.255.IPS e.max CAD for PlanMill LT A4 / B32.256.IPS e.max CAD for PlanMill LT B1 / B32.257.IPS e.max CAD for PlanMill LT B2 / B32.258.IPS e.max CAD for PlanMill LT B3 / B32.259.IPS e.max CAD for PlanMill LT B4 / B32.260.IPS e.max CAD for PlanMill LT C1 / B32.261.IPS e.max CAD for PlanMill LT C2 / B32.262.IPS e.max CAD for PlanMill LT C3 / B32.263.IPS e.max CAD for PlanMill LT C4 / B32.264.IPS e.max CAD for PlanMill LT D2 / B32.265.IPS e.max CAD for PlanMill LT D3 / B32.266.IPS e.max CAD for PlanMill LT D4 / B32.267.IPS e.max CAD for PlanMill LT BL1 / I12.268.IPS e.max CAD for PlanMill LT BL2 / I12.269.IPS e.max CAD for PlanMill LT BL3 / I12.270.IPS e.max CAD for PlanMill LT BL4 / I12.271.IPS e.max CAD for PlanMill LT BL1 / C14.272.IPS e.max CAD for PlanMill LT BL2 / C14.273.IPS e.max CAD for PlanMill LT BL3 / C14.274.IPS e.max CAD for PlanMill LT BL4 / C14.275.IPS e.max CAD for PlanMill LT BL1 / C16.276.IPS e.max CAD for PlanMill LT BL2 / C16.277.IPS e.max CAD for PlanMill LT BL3 / C16.278.IPS e.max CAD for PlanMill LT BL4 / C16.279.IPS e.max CAD for PlanMill LT BL1 / B32.280.IPS e.max CAD for PlanMill LT BL2 / B32.281.IPS e.max CAD for PlanMill LT BL3 / B32.282.IPS e.max CAD for PlanMill LT BL4 / B32.283.IPS e.max CAD for PlanMill HT A1 / I12.284.IPS e.max CAD for PlanMill HT A2 / I12.285.IPS e.max CAD for PlanMill HT A3 / I12.286.IPS e.max CAD for PlanMill HT A3,5 / I12.287.IPS e.max CAD for PlanMill HT A4 / I12.288.IPS e.max CAD for PlanMill HT B1 / I12.289.IPS e.max CAD for PlanMill HT B2 / I12.290.IPS e.max CAD for PlanMill HT B3 / I12.291.IPS e.max CAD for PlanMill HT B4 / I12.292.IPS e.max CAD for PlanMill HT C1 / I12.293.IPS e.max CAD for PlanMill HT C2 / I12.294.IPS e.max CAD for PlanMill HT C3 / I12.295.IPS e.max CAD for PlanMill HT C4 / I12.296.IPS e.max CAD for PlanMill HT D2 / I12.297.IPS e.max CAD for PlanMill HT D3 / I12.298.IPS e.max CAD for PlanMill HT D4 / I12.299.IPS e.max CAD for PlanMill HT A1 / C14.300.IPS e.max CAD for PlanMill HT A1 / C14.301.IPS e.max CAD for PlanMill HT A2 / C14.302.IPS e.max CAD for PlanMill HT A3 / C14.303.IPS e.max CAD for PlanMill HT A3,5 / C14.304.IPS e.max CAD for PlanMill HT A4 / C14.305.IPS e.max CAD for PlanMill HT B1 / C14.306.IPS e.max CAD for PlanMill HT B2 / C14.307.IPS e.max CAD for PlanMill HT B3 / C14.308.IPS e.max CAD for PlanMill HT B4 / C14.309.IPS e.max CAD for PlanMill HT C1 / C14.310.IPS e.max CAD for PlanMill HT C2 / C14.311.IPS e.max CAD for PlanMill HT C3 / C14.312.IPS e.max CAD for PlanMill HT C4 / C14.313.IPS e.max CAD for PlanMill HT D2 / C14.314.IPS e.max CAD for PlanMill HT D3 / C14.315.IPS e.max CAD for PlanMill HT D4 / C14.316.IPS e.max CAD for PlanMill HT BL1 / I12.317.IPS e.max CAD for PlanMill HT BL2 / I12.318.IPS e.max CAD for PlanMill HT BL3 / I12.319.IPS e.max CAD for PlanMill HT BL4 / I12.320.IPS e.max CAD for PlanMill HT BL1 / C14.321.IPS e.max CAD for PlanMill HT BL2 / C14.322.IPS e.max CAD for PlanMill HT BL3 / C14.323.IPS e.max CAD for PlanMill HT BL4 / C14.II.Пробные блоки из стеклокерамики IPS e.max CAD for E4D Impulse Probe Blocks / C14, в составе:1.IPS e.max CAD for E4D Impulse O1 / C14 (1шт.).2.IPS e.max CAD for E4D Impulse O2 / C14 (1шт.).3.IPS e.max CAD for E4D Impulse V1 / C14 (1шт.).4.IPS e.max CAD for E4D Impulse V2 / C14 (1шт.).5.IPS e.max CAD for E4D Impulse V3 / C14 (1шт.).III.Стартовые блоки из стеклокерамики IPS e.max CAD for PlanMill Impulse Starter Blocks / C14, в составе:1.IPS e.max CAD for PlanMill Impulse O1 / C14 (1шт.).2.IPS e.max CAD for PlanMill Impulse O2 / C14 (1шт.).3.IPS e.max CAD for PlanMill Impulse V1 / C14 (1шт.).4.IPS e.max CAD for PlanMill Impulse V2 / C14 (1шт.).5.IPS e.max CAD for PlanMill Impulse V3 / C14 (1шт.). |
Наименование организации – заявителя | ООО "Ивоклар Вивадент" |
Место нахождения организации-заявителя | 115432, Россия, г. Москва, проспект Андропова, д. 18, стр. 6 |
Юридический адрес организации-заявителя | 115432, Россия, г. Москва, проспект Андропова, д. 18, стр. 6 |
Наименование организации-производителя или организации-изготовителя | "Ивоклар Вивадент АГ" |
Место нахождения организации-производителя или организации – изготовителя | , Лихтенштейн, Ivoclar Vivadent AG, Bendererstrasse 2, 9494 Schaan, Liechtenstein |
Юридический адрес организации-производителя или организации – изготовителя | , Лихтенштейн, Ivoclar Vivadent AG, Bendererstrasse 2, 9494 Schaan, Liechtenstein |
ОКП/ОКПД2 | 93 9100 |
Класс потенциального риска применения медицинского изделия | 2а |
Назначение медицинского изделия, установленное производителем | |
Адрес места производства или изготовления медицинского изделия | 1. Ivoclar Vivadent AG, Bendererstrasse 2, 9494, Schaan, Liechtenstein.2. Ivoclar Vivadent Manufacturing Inc, 500 Memorial Drive, Somerset, NJ, 08873, USA.3. Ivoclar Vivadent Manufacturing GmbH, Via-Gustav-Flora 32, 39025 Naturno (BZ), Italy |
Контакты производителя медицинского изделия | |
Контакты дистрибутора в России №1 | |
Контакты дистрибутора в России №2 | |
Контакты дистрибутора в России №3 | |
Документы доступные для скачивания | Регистрационное удостоверение |