РУ № РЗН 2014/2278 от 01 августа 2022 года
  • Центр испытаний и регистрации медицинских изделий. ООО «ЦИРМИ»
  • INFO@GOSZDRAVNADZOR.RU
115487, город Москва

ул. Нагатинская, д. 16

+7 (495) 199-72-57

+7 (968) 480-70-88

РУ № РЗН 2014/2278 от 01 августа 2022 года

Номер РУ РЗН 2014/2278
Класс опасности 2а (медицинские изделия со средним классом опасности)
Код ОКП/ОКПД2 32.50.13.110
Дата выдачи РУ 01 августа 2022 года
Дата окончания РУ Действует бессрочно
Вид медицинского изделия
см. приложение
Номер записи в реестре 65176
Наименование медицинского изделия Катетеры урологические с принадлежностями для катетеризации I. Катетеры: Nelation catheter; Silicone Foley Catheters; Sterile Foley Catheters; Suprapubic Catheter Sets; II. Катетеры: Bard 5 Fr Straight Catheter; Bard A-Trac Balloon Dilation Catheter; Bard Balloon Dilation Catheter; Bard Clean-Cath Sterile Catheter; Bard Polyurethane Ureteral Catheters; Bard Urodynamic Catheter; Red Rubber All-Purpose Urethral Catheter; Round Drains; Bard Penrose Drains. III. Катетеры: 1. Мочеточниковые (уретеральные) катетеры Ureteral Catheters: Ureteral Catheter, Cylindrica; SELECTIP Ureteral Catheter Set, Cylindric; SELECTIP Ureteral Catheter Set, Olive; Ureteral Catheter, CHEVASSU; Ureteral Catheter, Cylindrical; Ureteral Catheter, Extension and Injection Set; Ureteral Catheter, Extension Stylet; Ureteral Catheter, Injection Adapter; Ureteral Catheter, Kempten acc. to Gumpinger; Ureteral Catheter, Olive Tip; Ureteral Catheter, Olive Tip; Ureteral Catheter, Universal; Ureteral Catheter, Universal Sheath acc. to WORDEHOFF / FROHLICH; Ureteral Catheter, WODRUFF Pflaumer. 2. Внутриуретальные катетеры Intra Urethral Catheter Intra Urethral Catheter, acc. to BARNES; Intra Urethral Catheter, Self Retaining. 3. Пиелопластиковые катетеры Pyeloplasty Catheters: Pyeloplasty Catheter, acc. to Frohlich; Pyeloplasty Catheter, Multipurpose Stent; Pyeloplasty Catheter, Ureteral Bypass Set. 4. Измерительные катетеры Universal Measuring Catheters: Universal Measuring Catheter, PIGTAIL Figuration; Universal Measuring Catheter, STRAIGHT Figuration; Urethral Measuring Catheter. 5. Дренажные катетеры и сеты Drainage Catheter / Set: Drainage Exchange Set, Basket Version; Drainage, ANGIOLENE Direct Puncture Set, Pigtail Version; Drainage, Bile Duct Examination Catheter, Figuration 1; Drainage, Bile Duct Examination Catheter, Figuration 3; Drainage, Bile Duct Examination Catheter, Figuration 4; Drainage, Bile Duct Examination Catheter, Figuration 5; Drainage, Biliary Endophrosthesis Set with Flared Proximal End; Drainage, Cannula and Obdurator Set; Drainage, DIJKSTRA, Direct Puncture Set, Pigtail Drainage Catheter; Drainage, Direct Puncture Set, J Curved Version; Drainage, Drainage Direct Puncture Set acc. to OTTO; Drainage, Drainage Direct Puncture Set acc. to OTTO, Loop Technique; Drainage, Drainage Direct Puncture Set, SCHUELLER Set, Pigtail Version; Drainage, Drainage Direct Puncture Set, SCHUELLER Set, Pigtail Version, MS; Drainage, Drainage Set acc. to OTTO, Pigtail Version, MS; Drainage, Drainage, Bile Duct Examination Catheter, Figuration 2; Drainage, GASTROTOP Abscess Drainage Set, Pigtail Version; Drainage, GASTROTOP Abscess Drainage Set, PUROFLEX, Basket Version; Drainage, GASTROTOP Abscess Drainage Set, PUROFLEX, Loop Technique; Drainage, GASTROTOP Replacement Abscess Drainage Catheter, PUROFLEX, Loop Technique; Drainage, GASTROTOP Sump Drainage Set, Pigtail Version; Drainage, GASTROTOP Sump Drainage Set, PUROFLEX, 2 Lumen, J Curved Version; Drainage, GASTROTOP, Percutaneouse Biliary Endophrosthesis Set; Drainage, GASTROTOP, Percutaneouse Gastrostomy Set; Drainage, HARZMANN Disc; Drainage, Initial Drainage Catheter for Biliary Endophrosthesis Set; Drainage, Kidney Cyst Puncture Set, Pigtail Version; Drainage, Live Abscess Drainage Set, Basket Version; Drainage, OTTO Needle, Puncture Needle; Drainage, OTTO Needle, Puncture Needle, Three Part; Drainage, Pediatric Drainage Set ace. to OTTO; Drainage, Pediatric Nephrostomy Drainage Catheter, UROSOFT, Pigtail Version; Drainage, PTC Damage Set, Straight Catheter Set; Drainage, PTC Drainage Catheter, Replacement Catheter, Loop Technique Version; Drainage, PTC Drainage Catheter, Replacement Catheter, Pigtail Version; Drainage, PTC Drainage Catheter, Replacement Catheter, Straight Version; Drainage, PTC Drainage Set Pigtail; Drainage, PTC Drainage Set, Loop Technique Set; Drainage, PUSS Ureteral Catheter; Drainage, Replacement Abscess Drainage Catheter, Basket Version; Drainage, Replacement Abscess Drainage Catheter, PUROFLEX, Pigtail Version; Drainage, Replacement Drainage Catheter acс. to OTTO, Loop Technique; Drainage, Replacement Drainage Catheter acс. to OTTO, Pigtail Version; Drainage, Replacement Drainage Catheter SOFT DRAIN, 1 Lumen; Drainage, Replacement Drainage Catheter, PUROFLEX, Pigtail Version; Drainage, Replacement Drainage Catheter, SCHUELLER Set, Pigtail Version; Drainage, Repositioning Catheter Set A; Drainage, Repositioning Catheter Set B; Drainage, Repositioning Catheter; Drainage, SOFT DRAIN Abscess Drainage Set, Loop Technique; Drainage, SOFT DRAIN Direct Puncture Set, J Curved Version, 1 Lumen; Drainage, SOFT DRAIN Drainage Set, J Curved Version, 1 Lumen; Drainage, SOFT DRAIN Drainage Set, Pigtail Version, Lumen 1; Drainage, SOFT DRAIN Sump Drain Catheter, J Curved Version, 2 Lumen; Drainage, SOFT DRAIN Sump Drainage Set, 2 Lumen, J Curved Version; Drainage, SOFT DRAIN Sump Drainage Set, J Curved Version; Drainage, SOFT DRAIN, Sump Drainage Set, 2 Lumen, without Needle; Drainage, Vesico Exchange Catheter; Drainage, Vesico Exchange Set for Supra Pubic Drainage; Drainage, Vesico Set for Supra Pubic Drainage; Endoplint Set, PUROFLEX; NEPHROPUR Drainage Catheter, PUROFLEX, Replacement Catheter, Basket Version; NEPHROPUR Drainage Catheter, PUROFLEX, Replacement Catheter; NEPHROPUR Drainage Catheter, PUROFLEX, Replacement Catheter, Loop Technique; Nephrostomy Drainage Catheter, Replacement Catheter, Pigtail Version; Pediatric Nephrostomy Drainage Catheter, Replacement Catheter, Pigtail Version; Percutaneouse Ureterotomy Stent Set, PUROFLEX, acc. to Korth; SOFT DRAIN Direct Puncture Set, Pigtail Version; SOFT DRAIN Drainage Catheter, Replacement Catheter, Pigtail Version; UROSOFT Nephrostomy Catheter, Basket Version; Jet Lyse Catheter. IV. Принадлежности для катетеризации: 1. Проводники: Bard Hydro-Glide Guidewires Bard Lubriwire Guidewires Floppy Tip Guidewires 2. Адаптеры: Bard Ureteral Catheter Adapters Ureteral Catheter Injection Adapter Syringe for Jet Lysis with Rotating Adapter Drainage, Universal Adapter, Female Luer Lock, Funnel Small Drainage, Universal Adapter, Female Luer Lock, Male Connecting Piece Drainage, Universal Adapter, Female Luer Lock, Male Luer Lock Drainage, Universal Adapter, Male Connecting Piece, Funnel Small Drainage, Universal Adapter, Male Luer Lock, Funnel Large Drainage, Universal Adapter, Reducing Piece, 2 Way Stopcock with Female Luer Lock Drainage, Universal Adapter, Reducing Piece, Female Luer Lock Drainage, Universal Adapter, Reducing Piece, Funnel Small Drainage, Universal Adapter, Reducing Piece, Male Luer Lock 3. Коннекторы: Drainage, Ureteral Catheter Connector for UNS-TA Ureteral Catheter Connector, Female Luer Lock Ureteral Catheter Connector, Male Luer Lock Ureteral Catheter Connector, Reducing Piece Ureteral Catheter Connector, Tuohy Borst Adapter 4. Зажимы: Drainage, Sliding Clamp for Catheter Bard Cunningham Clamp Bard Platinum Class Non-Retracting Grasping Forceps 5. Спринцовки: Bulb Irrigation Syringe Toomey and Piston Syringes 6. Шприц-инжектор: Syringe for Jet Lysis with Rotating Adapter 7. Экстраторы: Highflex Baskets, 3 Wires, Helical Highflex Baskets, 3 Wires, Parallel Highflex Baskets, 4 Wires, Helical Highflex Baskets, 4 Wires, Parallel Highflex Baskets, 5 Wires, Helical Highflex Baskets, 5 Wires, Parallel Highflex Baskets, 6 Wires, Helical Highflex Baskets, 6 Wires, Parallel Bard Ellik Evacuator Bard Platinum Class Flat Wire Stone Baskets and MINI Flat Bard Torque-Stable Helical Stone Baskets Reliavac 100cc Evacuator Kits Reliavac 400cc Evacuator Kits Three-Spring 400cc Evacuator Kits 8. Пластины иммобилизационные: HARZMANN Splint JONAS Splint 9. Урологические дилататоры: PTFE Distance Catheter Accessories Dilatation, Initial Dilator Accessories Dilatation, Renal Dilatation with Sheath Accessories Dilatation, Renal Dilatation, Complete Set Accessories Dilatation, Renal Dilatation, Partia1Set Accessories Dilatation, Renal Dilator Accessories Dilatation, Sheat from Ureteral Dilatation and Manipulation Set Accessories Dilatation, Step Ureteral Dilatation Set Accessories Dilatation, Ureteral Dilatation and Manipulation Set, acc. to Jenner Accessories Dilatation, Ureteral Dilatation and Manipulation Set Accessories Dilatation, Ureteral Dilatation Set Accessories Dilatation, Vessel Diatation, HIGHFLOW Material Accessories Dilatation, Vessel Diatator Accessories Dilatation, Vessel Diatator Set 10. Дуоденальные зонды: Duodenal Probe, Closed Tip Set, PUROFLEX Duodenal Probe, Closed Tip, Replacement Catheter, PUROFLEX Duodenal Probe, Open Tip Set, PUROFLEX Duodenal Probe, Open Tip, Replacement Catheter, PUROFLEX Duodenal Probe Adapter 11. Емкости для сбора мочи: Center Entry Urinary Drainage Bag Cytoscopic Irrigation Bag Urinary Drainage Bags, diverse Foleys 12. Трубки: Bard Minnesota Four Lumen Tube Bard T-Tubes 13. Футляры: Penile Sheaths Bardic Uro-Sheath Incontinence Device 14. Иглы: Brachytherapy Needles 15. Фильтр для слизи: Mucous Specimen Trap 16. Петля: ProMan Series Bard C-Max Cutting Loop 17. Резектор: ProMax Series Max-Blade Coagulating Resector 18. Пластинка: ProMax Series Bard V-Max Roller Bar 19. Диски: ReliaSeal Adhesive Discs 20. Фиксатор катетера: Catheter Strap 21. Принадлежности для эксторакорпоральной перфузии: Extracorporeal Perfusion Packs 22. Принадлежности для перкутанного доступа к почке: Percoutaneous Renal Access Sets 23. Мочесборники: Sterile Urine Collection Devices 24. Уриметр: Urimeter 25. Подвески сосуда: Vessel Slings 26. Емкость для слизи: Mucos Pot.
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. Bard Sdn. Bhd., Lot 57C Kulim Industrial Estate, 09000 Kulim, Kedah, Malaysia. 4. C.R. Bard, Inc., 8195 Industrial Boulevard, Covington, Georgia, 30014, USA.
Информация о регистрации медицинских изделий здесь.