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 01.08.2022 № РЗН 2014/2278
На медицинское изделие
Катетеры урологические с принадлежностями для катетеризацииI. 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.
Настоящее регистрационное удостоверение выдано
ООО "Бектон Дикинсон Восток"
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:
см. приложение
Класс потенциального риска применения
медицинского изделия: 2а
Код Общероссийского классификатора продукции для
медицинского изделия: 32.50.13.110
медицинского изделия: 32.50.13.110
Приказом Росздравнадзора от 01.08.2022 № ________
Допущено к обращению на территории Российской Федерации.
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