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 27.02.2017 № РЗН 2014/2278
На медицинское изделие
Катетеры урологические с принадлежностями для катетеризацииI. Катетеры:
Nelation catheter (вид 209970);
Silicone Foley Catheters (вид 155670);
Sterile Foley Catheters (вид 155670);
Suprapubic Catheter Sets (вид 125880);
II. Катетеры:
Bard 5 Fr Straight Catheter (вид 155670);
Bard A-Trac Balloon Dilation Catheter (вид 176290);
Bard Balloon Dilation Catheter (вид 176290);
Bard Clean-Cath Sterile Catheter (вид 266190);
Bard Polyurethane Ureteral Catheters (вид 260510);
Bard Urodynamic Catheter (вид 305630);
Red Rubber All-Purpose Urethral Catheter (вид 209970);
Round Drains (вид 152650);
Bard Penrose Drains (вид 248810);
III. Катетеры:
1. Мочеточниковые (уретеральные) катетеры Ureteral Catheters:
Ureteral Catheter, Cylindrical (вид 260510);
SELECTIP Ureteral Catheter Set, Cylindric (вид 260510);
SELECTIP Ureteral Catheter Set, Olive (вид 260510);
Ureteral Catheter, CHEVASSU (вид 260510);
Ureteral Catheter, Cylindrical (вид 260510);
Ureteral Catheter, Extension and Injection Set (вид 159960);
Ureteral Catheter, Extension Stylet (вид 237770);
Ureteral Catheter, Injection Adapter (вид 176330);
Ureteral Catheter, Kempten acc. to Gumpinger (вид 260510);
Ureteral Catheter, Olive Tip (вид 260510);
Ureteral Catheter, Olive Tip (вид 260510);
Ureteral Catheter, Universal (вид 260510);
Ureteral Catheter, Universal Sheath acc. to WORDEHOFF / FROHLICH (вид 159960);
Ureteral Catheter, WODRUFF Pflaumer (вид 260510);
2. Внутриуретальные катетеры Intra Urethral Catheter
Intra Urethral Catheter, acc. to BARNES (вид 260510);
Intra Urethral Catheter, Self Retaining (вид 260510);
3. Пиелопластиковые катетеры Pyeloplasty Catheters:
Pyeloplasty Catheter, acc. to Frohlich (вид 268550);
Pyeloplasty Catheter, Multipurpose Stent (вид 218070);
Pyeloplasty Catheter, Ureteral Bypass Set (вид 260510);
4. Измерительные катетеры Universal Measuring Catheters:
Universal Measuring Catheter, PIGTAIL Figuration (вид 305630);
Universal Measuring Catheter, STRAIGHT Figuration (вид 305630);
Urethral Measuring Catheter (вид 176380);
5.Дренажные катетеры и сеты Drainage Catheter / Set:
Drainage Exchange Set, Basket Version (вид 268550);
Drainage, ANGIOLENE Direct Puncture Set, Pigtail Version (вид 268550);
Drainage, Bile Duct Examination Catheter, Figuration 1 (вид 227510);
Drainage, Bile Duct Examination Catheter, Figuration 3 (вид 227510);
Drainage, Bile Duct Examination Catheter, Figuration 4 (вид 227510);
Drainage, Bile Duct Examination Catheter, Figuration 5 (вид 227510);
Drainage, Biliary Endophrosthesis Set with Flared Proximal End (вид 218050);
Drainage, Cannula and Obdurator Set (вид 125900);
Drainage, DIJKSTRA, Direct Puncture Set, Pigtail Drainage Catheter (вид 268550);
Drainage, Direct Puncture Set, J Curved Version (вид 268550);
Drainage, Drainage Direct Puncture Set acc. to OTTO (вид 268550);
Drainage, Drainage Direct Puncture Set acc. to OTTO, Loop Technique (вид 268550);
Drainage, Drainage Direct Puncture Set, SCHUELLER Set, Pigtail Version (вид 268550);
Drainage, Drainage Direct Puncture Set, SCHUELLER Set, Pigtail Version, MS (вид 268550);
Drainage, Drainage Set acc. to OTTO, Pigtail Version, MS (вид 268550);
Drainage, Drainage, Bile Duct Examination Catheter, Figuration 2 (вид 227510);
Drainage, GASTROTOP Abscess Drainage Set, Pigtail Version (вид 328470);
Drainage, GASTROTOP Abscess Drainage Set, PUROFLEX, Basket Version (вид 328470);
Drainage, GASTROTOP Abscess Drainage Set, PUROFLEX, Loop Technique (вид 260110);
Drainage, GASTROTOP Replacement Abscess Drainage Catheter, PUROFLEX, Loop Technique (вид 328470);
Drainage, GASTROTOP Sump Drainage Set, Pigtail Version (вид 328470);
Drainage, GASTROTOP Sump Drainage Set, PUROFLEX, 2 Lumen, J Curved Version (вид 328470);
Drainage, GASTROTOP, Percutaneouse Biliary Endophrosthesis Set (вид 227510);
Drainage, GASTROTOP, Percutaneouse Gastrostomy Set (вид 268590);
Drainage, HARZMANN Disc (вид 227510);
Drainage, Initial Drainage Catheter for Biliary Endophrosthesis Set (вид 227510);
Drainage, Kidney Cyst Puncture Set, Pigtail Version (вид 268550);
Drainage, Live Abscess Drainage Set, Basket Version (вид 152650);
Drainage, OTTO Needle, Puncture Needle (вид 329730);
Drainage, OTTO Needle, Puncture Needle, Three Part (вид 329730);
Drainage, Pediatric Drainage Set ace. to OTTO (вид 268550);
Drainage, Pediatric Nephrostomy Drainage Catheter, UROSOFT, Pigtail Version (вид 268550);
Drainage, PTC Damage Set, Straight Catheter Set (вид 227510);
Drainage, PTC Drainage Catheter, Replacement Catheter, Loop Technique Version (вид 227510);
Drainage, PTC Drainage Catheter, Replacement Catheter, Pigtail Version (вид 227510);
Drainage, PTC Drainage Catheter, Replacement Catheter, Straight Version (вид 227510);
Drainage, PTC Drainage Set Pigtail (вид 227510);
Drainage, PTC Drainage Set, Loop Technique Set (вид 227510);
Drainage, PUSS Ureteral Catheter (вид 260510);
Drainage, Replacement Abscess Drainage Catheter, Basket Version (вид 152650);
Drainage, Replacement Abscess Drainage Catheter, PUROFLEX, Pigtail Version (вид 152650);
Drainage, Replacement Drainage Catheter acс. to OTTO, Loop Technique (вид 152650);
Drainage, Replacement Drainage Catheter acс. to OTTO, Pigtail Version (вид 152650);
Drainage, Replacement Drainage Catheter SOFT DRAIN, 1 Lumen (вид 152650);
Drainage, Replacement Drainage Catheter, PUROFLEX, Pigtail Version (вид 152650);
Drainage, Replacement Drainage Catheter, SCHUELLER Set, Pigtail Version (вид 152650);
Drainage, Repositioning Catheter Set A (вид 152630);
Drainage, Repositioning Catheter Set B (вид 152630);
Drainage, Repositioning Catheter (вид 152630);
Drainage, SOFT DRAIN Abscess Drainage Set, Loop Technique (вид 152630);
Drainage, SOFT DRAIN Direct Puncture Set, J Curved Version, 1 Lumen (вид 152630);
Drainage, SOFT DRAIN Drainage Set, J Curved Version, 1 Lumen (вид 152630);
Drainage, SOFT DRAIN Drainage Set, Pigtail Version, Lumen 1 (вид 152630);
Drainage, SOFT DRAIN Sump Drain Catheter, J Curved Version, 2 Lumen (вид 152650);
Drainage, SOFT DRAIN Sump Drainage Set, 2 Lumen, J Curved Version (вид 152630);
Drainage, SOFT DRAIN Sump Drainage Set, J Curved Version (вид 152630);
Drainage, SOFT DRAIN, Sump Drainage Set, 2 Lumen, without Needle (вид 152630);
Drainage, Vesico Exchange Catheter (вид 125880);
Drainage, Vesico Exchange Set for Supra Pubic Drainage (вид 125880);
Drainage, Vesico Set for Supra Pubic Drainage (вид 125880);
Endoplint Set, PUROFLEX (вид 125880);
NEPHROPUR Drainage Catheter, PUROFLEX, Replacement Catheter, Basket Version (вид 268550);
NEPHROPUR Drainage Catheter, PUROFLEX, Replacement Catheter (вид 268550);
NEPHROPUR Drainage Catheter, PUROFLEX, Replacement Catheter, Loop Technique (вид 268550);
Nephrostomy Drainage Catheter, Replacement Catheter, Pigtail Version (вид 268550);
Pediatric Nephrostomy Drainage Catheter, Replacement Catheter, Pigtail Version (вид 268550);
Percutaneouse Ureterotomy Stent Set, PUROFLEX, acc. to Korth (вид 159920);
SOFT DRAIN Direct Puncture Set, Pigtail Version (вид 152630);
SOFT DRAIN Drainage Catheter, Replacement Catheter, Pigtail Version (вид 152650);
UROSOFT Nephrostomy Catheter, Basket Version (вид 268550);
Jet Lyse Catheter (вид 210290);
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
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
Класс потенциального риска применения
медицинского изделия: 2а
Код Общероссийского классификатора продукции для
медицинского изделия: 94 3630
медицинского изделия: 94 3630
Приказом Росздравнадзора от 27.02.2017 № ________
Допущено к обращению на территории Российской Федерации.
Руководитель Федеральной службы
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По надзору в сфере здравоохранения
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