РЗН 2014/2278 

Регистрационное удостоверение на медицинское изделие РЗН 2014/2278 
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ В СФЕРЕ
ЗДРАВООХРАНЕНИЯ
(РОСЗДРАВНАДЗОР)
РЕГИСТРАЦИОННОЕ УДОСТОВЕРЕНИЕ
НА МЕДИЦИНСКОЕ ИЗДЕЛИЕ
от 21.01.2015 № РЗН 2014/2278 
На медицинское изделие
Катетеры урологические с принадлежностями для катетеризации1. Катетеры урологические с принадлежностями для катетеризации (см. Приложение на 4 листах) 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, Cylindrical 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. Щприц-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 17.Фильтр для слизи: Mucous Specimen Trap 19. Петля: ProMan Series Bard C-Max Cutting Loop 20. Резектор: ProMax Series Max-Blade Coagulating Resector 21. Пластинка: ProMax Series Bard V-Max Roller Bar 22. Диски: ReliaSeal Adhesive Discs 23. Фиксатор катетера: Catheter Strap 24. Принадлежности для эксторакорпоральной перфузии: Extracorporeal Perfusion Packs 25. Принадлежности для перкутанного доступа к почке: Percoutaneous Renal Access Sets 26. Мочесборники: Sterile Urine Collection Devices 27. Уриметр: Urimeter 28. Подвески сосуда: Vessel Slings 29. Емкость для слизи: Mucos Pot.
Настоящее регистрационное удостоверение выдано
ООО "Бард Рус"
Производитель
"Ангиомед ГмбХ унд Ко. Медицинтекник КГ"
Место производства медицинского изделия
, Германия, , Angiomed GmbH & Co. Medizintechnik KG , Wachhausstrasse 6, 76227 Karlsruhe, Germany
Номер регистрационного досье № РЗН 2014/2278 
Вид медицинского изделия: —
Класс потенциального риска применения медицинского изделия: 2а
Код Общероссийского классификатора продукции для
медицинского изделия: 94 3630
Приказом Росздравнадзора от 21.01.2015 № ________
Допущено к обращению на территории Российской Федерации.
Руководитель Федеральной службы
По надзору в сфере здравоохранения
Ф.И.О
(печать)

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