ФС № 2005/583
Регистрационное удостоверение на медицинское изделие ФС № 2005/583
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ В СФЕРЕ
ЗДРАВООХРАНЕНИЯ
(РОСЗДРАВНАДЗОР)
РЕГИСТРАЦИОННОЕ УДОСТОВЕРЕНИЕ
НА МЕДИЦИНСКОЕ ИЗДЕЛИЕ
от 20.04.2005 № ФС № 2005/583
На медицинское изделие
Катетеры для радиологии с принадлежностями для катетеризации (см. Приложение на 11 листах)I. Катетеры производства Bard Peripheral Vascular, Inc.:
Opti-Plast XT-Xtra-thin PTA Catheters - Lowest Profile Performance
Opti-Plast XL-Xtra-large PTA Catheters - Lowest Profile Performance
Opti-Plast PTA Catheters
Ultraverse PTA Catheters - Premium Nylon Platform
Bard Tru-Trac PTA Catheters
PAC Balloon Dilatation Catheters
CENTURION Balloon Dilatation Catheters
CONQUEST Balloon Dilatation Catheters
II. Катетеры производства Angiomed GmbH & Co. Medizintechnik KG:
Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Cobra Version
Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Divers Version
Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Headhunter Version
Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Hepatica Communis Version
Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Hook Version
Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Judkins Version
Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Newton Version
Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Pigtail Version
Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Renal Version
Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Shepered Hook Version
Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Simmons Sidewinder Version
Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Straight Version
Angiomed Angiography Catheters, ANGIOPASS PLUS, Braided Shaft, Soft Tip, Hepatica Communis Version
Angiomed Angiography Catheters, ANGIOPASS PLUS, Braided Shaft, Soft Tip, Shephered Hook Version
Angiomed Angiography Catheters, ANGIOPASS PLUS, Braided Shaft, Soft Tip, Straight Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Cobra Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Divers Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Headhunter Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Judkins Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Multipurpose Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Pigtail Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Simmons Sidewinder Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Cobra Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Divers Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Headhunter Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Judkins Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Multipurpose Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Pigtail Version
Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Simmons Sidewinder Version
Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Cobra Version
Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Divers Version
Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Hook Version
Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Pigtail Version
Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Radiopaque, Pigtail Version
Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Radiopaque, Straight Version
Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Renal Version
Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Simmons Sidewinder Version
Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Straight Version
Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Bentson Hanafee Wilson Version
Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Cobra Version
Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Divers Version
Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Headhunter Version
Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Hook Version
Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Mani Version
Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Pigtail Version
Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Renal Version
Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Sheperd Hook Version
Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Simmons Sidewinder Version
Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Straight Version
Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Vertebralis Version
Dacryography Catheter
Galactography Catheter
Mamillary Dilator
Sialography Catheter
PAT RAT, Aspiration Catheter, 1 Lumen
III Катетеры производства Bard Access Systems:
Broviac catheters
Leonard catheters
Hickman catheters
Hohn catheters
Groshong catheters
Groshong PICC's
Groshong midline catheters
Per-Q-Cath P1CC
Per-Q-Cath Midline catheters
RadPICC catheters
ChronoFlex catheters
Hickman Hemodialysis catheters
Soft-Cell catheters
Opti-Flow catheters
Hemo-Glide catheters
Hemo-Split catheters
Flexxicon I and II catheters
Niagara catheters
Trialysis catheters
Vaccess Femoral catheters
Vaccess Subclavian jugular catheters
Vaccess jugular catheters
Arterial catheters
DuPen Long term epidural catheters
AngioCath intravenous catheters
IV.Принадлежности для катетеризации :
1. Проводники производства Angiomed GmbH & Co. Medizintechnik KG:
Amplatz, Moveable Core, J Tip, Stainless Steel, PTFE Coated
Amplatz, Moveable Core, Straight, Stainless Steel, PTFE Coated
BARDSe1ect Range, Amplatz, Moveable Core, J Tip, Stainless Steel, PTFE Coated
BARDSe1ect Range, Amplatz, Moveable Core, Straight, Stainless Steel, PTFE Coated
BARDSe1ect Range, Standard, Fixed Core, Double Ended, J Tip, Stainless Steel, PTFE Coated
BARDSeIect Range, Standard, Fixed Core, 3 Tip, Stainless Steel, PTFE Coated
BARDSe1ect Range, Standard, Fixed Core, Straight, Stainless Steel, PTFE Coated
BARDSeIect Range, Standard, Moveable Core, J Tip, Stainless Steel, PTFE Coated
BARDSe1ect Range, Standard, Moveable Core, Straight, Stainless Steel, PTFE Coated
Bentson, Fixed Core, Straight, Stainless Steel, PTFE Coated
Heavy Duty, Fixed Core, Straight, Stainless Steel, PTFE Coated
Interventional Guide Wire, Fixed Core, Angled, Nitinol
Interventional Guide Wire, Fixed Core, J Tip, Nitinol
Interventional Guide Wire, Fixed Core, Straight, Nitinol
Portacaval Guiding Probe, Fixed Core, Straight, Nitinol
Soft Torque, WHITE WIRE, Fixed Core, Straight, Nitinol, PTFE Coated
Standard, Fixed Core, Double Ended, J Tip, Stainless Steel
Standard, Fixed Core, Double Ended, J Tip, Stainless Steel, PTFE Coated
Standard, Fixed Core, J Tip, Stainless Steel
Standard, Fixed Core, J Tip, Stainless Steel, PTFE Coated
Standard, Fixed Core, Straight, Stainless Steel
Standard, Fixed Core, Straight, Stainless Steel, PTFE Coated
Standard, Moveable Core, J Tip, Stainless Steel
Standard, Moveable Core, J Tip, Stainless Steel, PTFE Coated
Standard, Moveable Core, Straight, Stainless Steel
Standard, Moveable Core, Straight, Stainless Steel, PTFE Coated
Torque, BARDSe1ect Range, BLUE WIRE, Fixed Core, Angled, Nitinol, PTFE Coated
Ultra Torque, BARD Se1ect Range, BLACK WIRE, Fixed Core, Angled, Nitinol, FEP Coated
Ultra Torque, BARD Se1ect Range, BLACK WIRE, Fixed Core, Straight, Nitinol, FEP Coated
Ultra Torque, BARD SeIect Range, BLUE WIRE, Fixed Core, Straight, Nitinol, PTFE Coated
Ultra Torque, BLACK WIRE, Angled, Nitinol, FEP Coated
Ultra Torque, BLACK WIRE, Fixed Core, Straight, Nitinol, FEP Coated
Soft Torque, WHITE WIRE,Fixed Core, Angled, Nitinol, PTFE Coated
Torque, BLUE WIRE, Fixed Core, Angled, Nitinol, PTFE Coated
Torque, BLUE WIRE, Fixed Core, Straight, Nitinol, PTFE Coated
Guide Wires for Duodenal Stents (I)
Litholapaxy Wires, J Curved
Litholapaxy Wires, J Curved, PTFE Coated
Litholapaxy Wires, Straight Version, PTFE Coated
Litholapaxy Wires, Straight Version
PTC Guide Wires acc. to LUNDERQUIST
Safety Wires, Interventional, Straight Version
SCHULLER Exchange Wires, J Curved
SCHULLER Exchange Wires, J Curved, PTFE Coated
SCHULLER Exchange Wires, Straight Version
SCHULLER Exchange Wires, Straight Version, PTFE Coated
SCHULLER Litholapaxy Wires, Double Ended
SCHULLER Litholapaxy Wires, J Curved
SCHULLER Litholapaxy Wires, J Curved, PTFE Coated
SCHULLER Exchange Wires, J Curved, PTFE Coated
SCHULLER Exchange Wires, Straight Version
SCHULLER Exchange Wires, Straight Version, PTFE Coated
SCHULLER Litholapaxy Wires, Double Ended
SCHULLER Litholapaxy Wires, J Curved
SCHULLER Litholapaxy Wires, J Curved, PTFE Coated
Special Exchange Wires, J Curved
Special Exchange Wires, J Curved, PTFE Coated
Special Exchange Wires, PTFE Coated
Accessories Guide Wires, Pin Vise
2. Проводники производства Bard Access Systems:
Guidewires
3. Иглы производства Angiomed GmbH & Co. Medizintechnik KG:
Angiography Needles
Arterial Puncture Needle BARDSeIect Range, Standard Cut
Arterial Puncture Needle Standard Cut
BARDSe1ect Range, Percutaneouse Entry Needle, Standard Cut
CHIBA Needle Bevel Edged, 2 Part
CHIBA Needle Bevel Edged, 2 Part, Graduated
CHIBA Needle MS Cut, 2 Part
CHIBA Needle MS Cut, 2 Part, Graduated
Discography Set acc. to DR ZUBER
Initial Puncture Needle Trocar Cut, 3 Part
Initial Puncture Needle, Bevel Edged, 2 Part, Graduated, Model LORETTO
Initial Puncture Needle, Bevel Edged, 2 Part, Model LORETTO
Initial Puncture Needle, Bevel Edged, 2 Part, Model MERHEIM
Initial Puncture Needle, Bevel Edged, 2 Part, Model OLDENBURG
Initial Puncture Needle, Bevel Edged, 3 Part
Initial Puncture Needle, MS Cut, 1 Part
Initial Puncture Needle, MS Cut, 2 Part
Initial Puncture Needle, MS Cut, 3 Part
Initial Puncture Needle, MS Cut, 3 Part, Graduated
Needle, Collagene Injection Needle, Bevel Edged, 1Part
Needle, Hepatom Needle, Type I
Needle, Hepatom Needle, Type II
Percutaneouse Entry Needle modified acc. to Jantsch,
Percutaneouse Entry Needle, BARDSe1ect Range modified acc. to Jantsch
Percutaneouse Entry Needle, Standard Cut
Puncture Needle SUPER 4 modified ace. to Jantsch
Puncture Needle SUPER 4, BARDSe1ect Range modified acc. to Jantsch
Puncture Set acc. to STACKL
SUPER 4 Needle, Arterial Puncture Needle
SUPER 4 Needle, Puncture Needle, BARDSelect Range
Initial Needle Set, 2 Part, PTFE Catheter
Initial Puncture Needle, 2 Part, PTFE Catheter
LEIGEN Needle Set, 2 Part, PTFE Catheter
PTC Initial Needle Set, 1 Part, PE Catheter
Puncture Needle, 1 Part, PTFE Catheter
SENGE Needle, 1 Part, High Flow Catheter
Tumor Marking Set, Hook Wire
4. Иглы производства Bard Access Systems:
Hustead needles
Winged infusion sets with non-coring needle
Non-coring needles
Hypodermic needles
5.Интродюсеры производства Angiomed GmbH & Co. Medizintechnik KG:
Introducer Set with Haemostatic Valve
Introducer Set with Puncture Needle, Class IIa
Percutaneous Introducer Set, Version A, Class IIa
Percutaneous Introducer Set, Version B, Class IIa
Special Introducer Set
PAT RAT Introducer System, acc to STARCK
6. Интродюсеры производства Bard Access Systems:
Seldinger technique type introducers: Peel apart, Co-axial design
Sheath over-the-needle type introducers
Peel-apart micro introducers and excalibur introducers, Co-axial design (IV catheter)
Over the guidewire type vessel dilators
7. Принадлежности для ремонта катетеров призводства Bard Access Systems:
External catheter segments for Broviac and Hickman CV catheters
External catheter segments for Hickman and Leonard CV catheters
Hickman CV repair kit - extension legs
Groshong CV catheter repair kits for single lumen catheters
Groshong CV catheter repair kits for multi lumen catheters
Groshong CV catheter repair kit - extension legs
Per-Q-Cath P1CC repair connectors
DuPen epidural catheter repair kits
8. Порты производства Bard Access Systems:
M.R.I. Low profile infusion ports
M.R.I. Implanted ports (plastic or titanium stem)
M.R.I. Hard base implanted ports
M.R.I. Dual implanted ports (plastic or titanium)
Titanium Low profile implanted ports (Slim Port)
Titanium Dome implanted ports
Titanium implanted ports
SlimPort Rosenblatt dual low profile implanted ports
SlimPort ultra low profile M.R.I ports with titanium stem
X-Port low profile implanted ports
X-Port isp implanted ports
CathLink Standard Profile (SP) ports
CathLink Low Profile (LP) ports
CathLink Ultra-Low Profile (ULP) ports
9. Шунты производства Angiomed GmbH & Co. Medizintechnik KG:
Transjugular Intrahepatic Stent Shunt (TIPSS) Products, Porta Caval Set
Transjugular Intrahepatic Stent Shunt (TIPSS) Products, Porta Caval Guide Catheter, HIGHFLOW
Transjugular Intrahepatic Stent Shunt (TIPSS) Products, Porta Caval Guide Catheter, PTFE
Transjugular Intrahepatic Stent Shunt (TIPSS) Products, Porta Caval Introducer Set
Transjugular Intrahepatic Stent Shunt (TIPSS) Products, Porta Caval Needle
10. Коннекторы производства Angiomed GmbH & Co. Medizintechnik KG:
Contrast Media Connector, BARDSelect Range, Male and Female Luer Lock, Type B
Contrast Media Connector, BARDSelect Range, Male/Female Luer Lock, Type A
Contrast Media Connector, Male/Female Luer Lock, Type A
Contrast Media Connector, Male/Female Luer Lock, Type B
HIGH FLEX Connector, BARDSelect Range, Male to Female Luer Lock, Type A
HIGH FLEX Connector, BARDSelect Range, Type B
HIGH FLEX Connector, Male to Female Luer Lock, Type A
HIGH FLEX Connector, Male to Female Luer Lock, Type B
Pressure Connector, BARDSelect Range, Male to Female Luer Lock
Pressure Connector, BARDSelect Range, Male to Female Lur Lock
Pressure Connector, Male and Female Luer Lock, Typ B
Pressure Connector, Male Luer Lock to Two Way Stopcock
Pressure Connector, Male to Female Luer Lock, Typ A
11. Адаптеры производства Angiomed GmbH & Co. Medizintechnik KG:
Connecting Adapter, Female Luer Lock
Connecting Adapter, Male Luer Lock
Tuhey Borst Adapter
12. Краники производства Angiomed GmbH & Co. Medizintechnik KG:
2 Way Stopcock, Female Luer Lock
3 Way Stopcock, 2 Female Luer Lock
13. Емкости производства Angiomed GmbH & Co. Medizintechnik KG:
Section Bag without Bacteria Filter
Urine Bag with Bacteria Filter
Urine Bag without Bacteria Filter
Urine Leg Bag without Bacteria Filter
14. Расщепляющая оболочка интродюсера производства Angiomed GmbH & Co. Medizintechnik KG:
Accessories Introducer Split Sheath
15. Гемостатический клапан для катетеров производства Angiomed GmbH & Co. Medizintechnik KG:
Haemostatic Valve for Catheters, Diameter from 4-9F
Haemostatic Valve for Catheters, Diameter from 5-8F
16. Тромбоэкстраторы производства Angiomed GmbH & Co. Medizintechnik KG:
RAT Fragmentation Basket ace. to STARCK
RAT Fragmentation Basket with Flexible Tip ace. to STARCK
17. Дренажи производства Angiomed GmbH & Co. Medizintechnik KG:
Pericard Drainage Sets (Class III)
18. Фильтры производства Bard Peripheral Vascular, Inc.:
Simon Nitinol Filter
19. Фильтры производства Bard Access Systems:
0.22 Micron filter for use with epidural catheter
20. Инфляторы производства Bard Peripheral Vascular, Inc.:
Max 30 Inflation Device
Max 30i Inflation Device
21. Стилеты производства Bard Access Systems:
Coated stylets
Uncoated stylets
Threader stylets
22. Коннекторы производства Bard Access Systems:
Groshong Replacement Connectors
23. Скальпели производства Bard Access Systems:
Scalpels
24. Туннелеры производства Bard Access Systems:
Tunnelers
25. Расширительные сеты производства Bard Access Systems:
Extension sets
26. Зажимы производства Bard Access Systems:
Clamps
27. Инъекционные насадки производства Bard Access Systems:
Injection caps
28. Ножницы производства Bard Access Systems:
Scissors
29. Отделители вен производства Bard Access Systems:
Vein picks
30. Иглодержатели производства Bard Access Systems:
Needle holders
31. Щприц-инжектор производства Bard Access Systems:
Syringes
Flushing hubs
32. Зажимы производства Bard Access Systems:
Forceps
Настоящее регистрационное удостоверение выдано
Производитель
C.R. Bard GmbH (заводы: Bard Peripheral Vascular, Inc., США; Bard Access Systems, США)
Место производства медицинского изделия
ФРГ, Мексика, Пуэрто-Рико
Номер регистрационного досье № ФС № 2005/583
Вид медицинского изделия:
—
Код Общероссийского классификатора продукции для
медицинского изделия: ---
медицинского изделия: ---
Приказом Росздравнадзора от 20.04.2005 № ________
Допущено к обращению на территории Российской Федерации.
Руководитель Федеральной службы
По надзору в сфере здравоохранения
Ф.И.О
По надзору в сфере здравоохранения
Ф.И.О
(печать)
_подпись_
_подпись_