РУ № РЗН 2015/2486 от 01 августа 2022 года
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РУ № РЗН 2015/2486 от 01 августа 2022 года

Номер РУ РЗН 2015/2486
Класс опасности 2б (медицинские изделия с повышенным классом опасности)
Код ОКП/ОКПД2 32.50.22.195
Дата выдачи РУ 01 августа 2022 года
Дата окончания РУ Действует бессрочно
Вид медицинского изделия
см. приложение
Номер записи в реестре 65177
Наименование медицинского изделия Стенты и наборы стентирования для урологии Стенты: 1. memotherm Prostatic Ureteral stent. 2. memotherm Bulbar Urethral stent. 3. GREY STENT Vario Stent, Cystoscopic. 4. GREY STENT Vario Stent, Tiemann tip. 5. GREY STENT, Multi Function Stent AIK, Tiemann Tip. 6. GREY STENT, Multi Function Stent, Cystoscopic. 7. GREY STENT, Multi Function Stent, Tiemann Tip. 8. GREY STENT, Percutaneous Application Multi Fimction Stent, Tiemann Tip. 9. PUROFLEX Vario Stent, Cystoscopic. 10. PUROFLEX Vario stent, Tiemann Tip. 11. PUROFLEX, Multi Function Stent, Cystoscopic. 12. PUROFLEX , Multi Function Stent, Tiemann Tip. 13. Ureteral Stents, GREY STENT, Replacement Ureteral stent, Cystoscopic. 14. Ureteral Stents, PUROFLEX Replacement Ureteral stent, Percutaneous Application. 15. Ureteral Stents, PUROFLEX, Endoprosthesis. 16. Ureteral Stents, PUROFLEX, Replacement Ureteral stent, Cystoscopic. 17. Ureteral Stents, Pusher for Multifunction Stent, MBCS-GS. 18. Ureteral Stents, Pusher for Ureteral Stent, PUROFLEX, Adapted for 5F. 19. UROSOFT Vario stent, Cystoscopic. 20. UROSOFT Vario stent, Tiemann Tip. 21. UROSOFT, Multi Function Stent AIK, Tiemann tip. 22. UROSOFT, Multi Function Stent AIK, Cystoscopic. 23. UROSOFT, Multi Function Stent, Cystoscopic. 24. UROSOFT, Multi Function Stent, Tiemann tip. 25. UROSOFT Vario stent. Ureteral stent. 26. PUROFLEX Ureteral stent, AIK, Intra Operative Saxx Stent. 27. Urological stents. 28. Bard InLay Ureteral stent. 29. Silicone stents. Наборы для стентирования: 30. Repositioning set for memotherm Urethral stent. 31. Ureteral stents, Urosoft Ureteral Stent Set, Cystoscopic. 32. COMFORT KOMBISTENT Set, Percutaneous Application. 33. COMFORT KOMBISTENT Set, Tiemann Tip. 34. Endoprothesis Set, Cystoscopic. 35. FIRM Mulilength Probing and Placement Set, Percutaneous Application. 36. GREY STENT UROPATH Ureteral stent Set, Cystoscopic. 37. GREY STENT, Endoprosthesis Set, Percutaneous Application. 38. GREY STENT, Endoprosthesis Set AIK, Cystoscopic. 39. GREY STENT, Endoprosthesis Set AIK, Percutaneous Application. 40. GREY STENT, Endoprosthesis Set, Cystoscopic. 41. GREY STENT, Endoprosthesis Set, Tiemann Tip. 42. GREY STENT, Probing and Placement Set, Percutaneous Application. 43. PUROFLEX Pediatric Ureteral Stent Set, Percutaneous Application. 44. PUROFLEX, Endoprosthesis Set, Tiemann Tip. 45. PUROFLEX Pediatric Ureteral Stent Set, Cystoscopic. 46. PUROFLEX Ureteral Stent Set, Percutaneous Application, Multi Length. 47. PUROFLEX UROPATH Ureteral Stent Set, Cystoscopic. 48. PUROFLEX UROPATH Ureteral Stent Set, Tiemann Tip. 49. PUROFLEX UROPATH Ureteral Stent Set, Percutaneous Application. 50. PUROFLEX Cross Stent Set, Percutaneous Application. 51. PUROFLEX, Endoprosthesis Set AIK, Cystoscopic. 52. PUROFLEX, Endoprosthesis Set AIK, Tiemann Tip. 53. PUROFLEX, Endoprosthesis Set, Cystoscopic. 54. PUROFLEX, Endoprosthesis Set, Percutaneous Application. 55. PUROFLEX, Probing and Placement Set, Cystoscopic. 56. PUROFLEX, Probing and Placement Set, Tiemann Tip. 57. Replacement GREY STENT, Ureteral stent Set, Percutaneous Application. 58. SCHULLER Ureterotomy Stent Set. 59. SOFT Multilength Probing and Placement Set, Opend End Tip. 60. UROSOFT Ureteral stent Set, Percutaneous Application Multi Length. 61. Ureter Splinting Set, Cystoscopic. 62. Ureteral Stents, ECO SOFT, Ureteral Stent Set, Percutaneous Application. 63. Ureteral Stents, ECO SOFT, Ureteral Stent Set, Tiemann Tip. 64. Ureteral Stents, GREY STENT, Ureteral Stent Set, Cystoscopic. 65. Ureteral Stents, GREY STENT, Ureteral Stent Set, Percutaneous Application. 66. Ureteral Stents, GREY STENT, Ureteral Stent Set, Tiemann Tip. 67. Ureteral Stents, Injenction Combi Stent Set. 68. Ureteral Stents, PUROFLEX Ureteral Stent Set, Cystoscopic. 69. Ureteral Stents, PUROFLEX Ureteral Stent Set, AIK, Cystoscopic. 70. Ureteral Stents, PUROFLEX Ureteral Stent Set, AIK, Percutaneous Application. 71. Ureteral Stents, PUROFLEX Ureteral Stent Set, Percutaneous Application. 72. Ureteral Stents, PUROFLEX Ureteral Stent Set, Tiemann Tip. 73. UROSOFT KOMBISTENT Set, Percutaneous Application. 74. UROSOFT KOMBISTENT Set, Tiemann Tip. 75. UROSOFT Pediatric Ureteral Stent Set, Cystoscopic. 76. UROSOFT Probing and Placement Set, Open End Tip. 77. UROSOFT Tumor Stent Set, Percutaneous Application. 78. UROSOFT Ureteral Stent Set, AIK, Percutaneous Application. 79. UROSOFT Ureteral Stent Set, Pediatric Percutaneous Application. 80. UROSOFT UROPATH Ureteral Stent Set Cystoscopic. 81. UROSOFT UROPATH Ureteral Stent Set, Tiemann Tip. 82. UROSOFT UROPATH, Ureteral Stent Set, Percutaneous Application. 83. UROSOFT, Cross Stent Set, Percutaneous Application. 84. UROSOFT, Endoprosethesis Set AIK, Cystoscopic. 85. UROSOFT, Endoprosethesis Set AIK, Tiemann Tip. 86. UROSOFT, Endoprosethesis Set, Percutaneous Application. 87. UROSOFT, Endoprosethesis Set, Percutaneous. 88. UROSOFT, Endoprosethesis Set, Tiemann Tip. 89. UROSOFT, Probing and Placement Set, Cystoscopic. 90. UROSOFT, Probing and Placement Set, Percutaneous Application. 91. UROSOFT, Probing and Placement Set, Tiemann Tip. 92. UROSOFT Ureteral Stent Set, Percutaneous Application, VVR Version. 93. UROSOFT Ureteral Stent Set, Intra Operative. 94. GREY STENT Ureteral Stent Set, Intra Operative. 95. PUROFLEX Ureteral Stent Set, Intra Operative.
Заявитель (держатель РУ) ООО «Бектон Дикинсон Восток»
Фактический адрес заявителя 127051, Россия, Москва, ул. Садовая-Самотёчная, д. 24/27, эт. 2, пом. I, ком. 18
Юридический адрес заявителя 127051, Россия, Москва, ул. Садовая-Самотёчная, д. 24/27, эт. 2, пом. I, ком. 18
Изготовитель «Ангиомед ГмбХ унд Ко. Медицинтекник КГ»
Фактический адрес изготовителя , Германия, Angiomed GmbH & Co. Medizintechnik KG, Wachhausstrasse 6, 76227 Karlsruhe, Germany
Юридический адрес изготовителя , Германия, Angiomed GmbH & Co. Medizintechnik KG, Wachhausstrasse 6, 76227 Karlsruhe, Germany
Производственная площадка 1. Angiomed GmbH & Co. Medizintechnik KG, Wachhausstrasse 6, 76227 Karlsruhe, Germany. 2. Productos para El Cuidado de la Salud de CV, Carretera Internacional KM 6.5, Nogales Terrazas del Cid Sonora, 84000 Mexico. 3. Biomerics FMI, 1605 Enterprise Street, Athens, Texas, 75751, USA. 4. C.R. Bard, Inc., 8195 Industrial Boulevard, Covington, Georgia, 30014, USA.
Информация о регистрации медицинских изделий здесь.