Отсосы-аспираторы электрические медицинские Accuvac Basic и Accuvac Rescue, с… — инструкция и характеристики, РУ ФСЗ 2011/10345 | TenderMatch

Отсосы-аспираторы электрические медицинские Accuvac Basic и Accuvac Rescue, с принадлежностями — инструкция и характеристики

РУ: ФСЗ 2011/10345 · класс риска 2б

Производитель: "ВАЙНМАНН Эмердженси Медикал Технолоджи ГмбХ+ Ко. КГ" (Германия)

Вид изделия: Система аспирационная общего назначения, с питанием от сети

Автоматически отфильтрованный фрагмент инструкции по применению (страницы, где похоже, что есть таблица технических характеристик) — не полный документ. Карточка РУ на портале Росздравнадзора →

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Текст инструкции: технические характеристики

--- стр. 1 ---
I КОПИЯ
Certificate
The Certification Body of  
TLIV Rheinland LGA Products GmbH
hereby certifies that the organization
WEINMANN Emergency Medical  
Technology GmbH + Co. KG  
Frohbosestr. 12  
22525 Hamburg  
Deutschland
has established and applies a quality management system for medical devices
for the following scope:
Design and development, production, distribution  
and servicing of medical devices for  
emergency and transport medicine  
(see attachment for additional site included)
Proof has been furnished that the requirements specified in
EN ISO 13485:2012 
EN ISO 13485:2012/AC:2012
are fulfilled. The quality management system is subject to yearly surveillance.
Certificate Registration No.: SX 60088228 0001
An audit was performed. Report No.: 21201240 002
This Certificate is valid until: 30.06.2016
Akkreditiert durch
^  ___ -£• Zentralstelle der Lander
fur Gesundheitsschutz 
*  = = = = ^ | *  bei Arzneimilteln
V . , i f  und Medizinprodukten
ZLG-ZQ-995.00.01 -46
Date 28.08.2013
TUV Rheinland LGA Products GmbH - Tillystralie 2 - 90431 Nurnberg
Tel.: +49 221 806-1371 Fax: +49 221 806-3935 e-mail:cert-validity@de.tuv.com http://www.tuv.com/safety


--- стр. 2 ---
TUVRheinland
TIJV Rheinland 
LGA Products GmbH  
Tillystrafce 2, 90431 Niirnberg
Attachment to
Registration No.: SX 60088228 0001
Report No.: 21201240 002
Organization: WEINMANN Emergency Medical
Technology GmbH + Co. KG  
Frohbosestr. 12  
22525 Hamburg  
Deutschland
Scope: Additional site included:
WEINMANN Emergency Medical Technology GmbH + Co. KG
Siebenstiicken 14
24558 Henstedt-Ulzburg, Germany
A ctivities: Production and Service
Akkreditiertdurch
,• Zentralstelle der Lander
K i JP  ^  fur Gesundheitsschutz 
*  bei Arzneimilteln
I. , i f  und Medizinproduklen
''y v ZLG-ZQ-995.00.01-46
‘■ate: 2013-08-28
Certification Bo
Dipl.-Ing. I. Munkler
_


--- стр. 3 ---
®
Certificate
The Certification Body of  
TIJV Rheinland LGA Products GmbH
TUVRheinland
hereby certifies that the organization
WEINMANN Emergency Medical  
Technology GmbH + Co. KG  
Frohbosestr. 12  
22525 Hamburg  
Deutschland
has established and applies a quality management system 
for the following scope:
Design and development, production, distribution  
and servicing of medical devices for  
emergency and transport medicine  
(see attachment for additional site included)
Proof has been furnished that the requirements specified in
EN ISO 9001:2008
are fulfilled. The quality management system is subject to yearly surveillance.
Certificate Registration No.:
An audit was performed. Report No.: 
This Certificate is valid until:
SY 60088233 0001 
21201240 002 
30.06.2016
Date 28.08.2013
Certification Body
TUV Rheinland LGA Products GmbH - Tillystralie 2 - 90431 Niirnberg
Tel.:+49 221 806-1371 Fax: +49 221 806-3935 e-mail:cert-validity@de.hJv.com http://www.tuv.com/safety
Н Ф М О


--- стр. 4 ---
ttachment to  
isgistration No  
sport No.:
Organization:
S c o p e :
flte: 2013-08-
TUVRheinland
TUV Rheinland 
LGA Products GmbH  
Tillystrafte 2, 90431 Niirnberg
SY 60088233 0001  
21201240 002
WEINMANN Emergency Medical  
Technology GmbH + Co. KG  
Frohbosestr. 12  
22525 Hamburg  
Deutschland
Additional site included:
WEINMANN Emergency Medical Technology GmbH + Co. KG
Siebenstiicken 14
24558 Henstedt-Ulzburg, Germany
A ctivities: Production and Service
28


--- стр. 5 ---
A
®
ЕС Certificate TUVRheinland
Directive 93/42/ЕЕС Annex II, excluding Section 4  
Full Quality Assurance System  
Medical Devices
Registration No.: HD 60088226 0001  
Report No.: 21201240 002
lacturer: WEIIMMANN Emergency Medical
Technology GmbH + Co. KG  
Frohbosestr. 12  
22525 Hamburg  
Deutschland
:ts: Medical devices for emergency and transport medicine
(see attachment for products and sites included)  
Replaces Approval, Registration No.: HD 60086808 0001
! Date: 2018-06-30
I ied Body hereby declares that the requirements of Annex II, excluding section 4 of the directive  
E E C  have been met for the listed products. The above named manufacturer has established  
flies a quality assurance system, which is subject to periodic surveillance, defined by Annex II,
5 of the aforementioned directive. For placing on the market of class III devices covf  
■tificate an EC design-examination certificate according to Annex II, section 4 is redui*fe№^
Notifr
Date: 2013-08-28
2013-08-28
Dipl.-lng.
TUV Rheinland LGA Products GmbH - Tillystrafte 2 - 90431 Niirnberg
TUV Rheinland LGA Products GmbH is a Notified Body according to Directive 93/42/EEC  
concerning medical devices with the identification number 0197.


--- стр. 6 ---
TUVRheinland
TUV Rheinland 
LGA Products GmbH  
Tillystrafte 2, 90431 Nurnberg
■ttachment to 
irtificate
egistration No.: HD 60088226 0001
eport No.: 21201240 002
'anufacturer: WEINMANN Emergency Medical
Technology GmbH + Co. KG  
Frohbosestr. 12  
22525 Hamburg  
Deutschland
oducts included:
ergency and transport medicine
Suction pumps
Ventilators
todule systems
Pesuscitators
Ventilation masks
Patient hose systems
Pressure reducers
Click dial flowmeter
Ce£ibrillators-/Monitor systems


--- стр. 7 ---
TUVRheinland
TUV Rheinland 
LGA Products GmbH  
Tillystrafte 2, 90431 Nurnberg
Doc. 2/2,  Rev. 0
ttachment to  
iertificate
Registration No.: 
«port No.:
HD 60088226 0001  
21201240 002
lanufacturer: WEINMANN Emergency Medical  
Technology GmbH + Co. KG  
Frohbosestr. 12  
22525 Hamburg  
Deutschland
itional site included:
Emergency Medical Technology GmbH + Co. KG  
benstucken 14
1558 Henstedt-Ulzburg, Germany  
pivities: Production
2013-08-28
Notified Body JJ> / ^  %
TUVRheinlamJ
Dipl.-lng. I. Munkler*


--- стр. 8 ---
I, the undersigned
Dr. Florian Mohrle,
a Notary Public of this Free and Hanseatic City of Hamburg, Federal Republic of 
Germany, do hereby certify and attest that the foregoing copy is a true and faithful 
copy of the original deeds, which were presented to me today.
Hamburg, this 12th day of September, 2013
Dr. Florian Mohrle 
- Notary Public -


--- стр. 9 ---
[the undersigned
Dr. Florian Mohrle,
a  Notary Public of this Free and Hanseatic City of Hamburg, Federal Republic of 
Germany, do hereby certify and attest that the foregoing copy is a true and faithful 
copy of the notarially certified copy dated September 12, 2013.
Hamburg, this 13th day of September, 2013
1
Dr. Florian Mohrle 
- Notary Public -


--- стр. 10 ---
1 ■ I
s
m
Apostille
(Convention d e  La H aye du 5 octobre 1961)
1. Land: Bundesrepublik Deutschland 
Diese offentliche Urkunde
2. ist unterschrieben von Dr. Florian Mohrle
3. in der Eigenschaft als Notar
4. sie ist versehen mit dem Siegel/Stempel des 
Notars Dr. Florian Mohrle
Bestatigt
5. in Hamburg 6. am 16. Dezember 2013
7. durch die Prasidentin des Landgerichts
8. unter Nr. 9101 E/l 5189/2013
9. Siegel/Stempel 10. Unterschrift: