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of Regitation
OA
The Governing Board of
Q.A. International Certification Limited
hereby grants to
Hadeco, Inc
Registration No.: QAIC / JP / 0984 - A
(hereinafler called the Registered Company) the right to be listed in the Directory of Registered Companies in respect of
the services listed below. These services shall be offered by the Registered Company at or from only the address given
below in accordance with the emironmental management system in compliance with ISO 14001 :2015.
Address to which this Certificate refers
Head Office : 2-7- -11 Arima, Miyamae-ku, Kawasaki- -shi, KanagawaJapan
Approved Scope to which this Certificate refers
Design / Development, Manufacture and Servicing
(Repair of Filed Returns, Supply of User Manuals and Catalogues) of Medical Equipment
Signed for and on behalf of the Board
SCHEME MANAGER CHIEF EXECUTIVE
Certificate Issue Date : 28th September 2017 - Certificate Renewal Before : 29thSeptember 2018
Date of Initial Registration : 30th September 2011 - Re-Certification Before: 29th September2020
This Certificate of Registration is granted subject to the Regulations approved by the Board.
INTERNATIONAL QA International Certificaton Ltd.
Dudley Court
Dudley Road
Darlington
United Kingdom DL1 4GG
Tel: +44 (0)1325 384272
Fax: +44 (0)1325 480980
www qai.co.uk
The Governing Board of
Q.A. International Certification Limited
hereby grants to
Hadeco, Inc
Registration No.: QAIC / JP / 0983 - -A
(hereinafter called the Registered Company) the right to be listed in the Directory of Registered Companies in respect of
the services listed below. These services shall be offered by the Registered Company at or from only the address given
below in accordance with the quality management system in compliance with ISO 9001 :2015.
Address to which this Certificate refers
Head Office : 2-7-11 Arima, Miyamae-ku, Kawasaki-shi, Kanagawa Japan
Approved Scope to which this Certificate refers
Design / Development, Manufacture and Servicing
(Repair of Field Returns, Supply of User Manuals and Catalogues) of Medical Equipment
Signed for and on behalf of the Board
A
CHIEF EXECUTIVE SCHEME MANAGER
Certificate Issue Date : 8th September 2017: Certificate Expiry Date 9th September2018
Date of Initial Registration 6th September 2011 - Re-Certification Before : 9th September 2019
This Certificate of Registration is granted subject to the Regulations approved by the Board
QA INTERNATIONAL QA International Certification Ltd,
Dudley Court
Dudley Road
Darlington
United Kingdom DL1 4GG
Tel: +44 (0) 1325 384272
Fax: +44 (0)1325 480980 cavered
www.qai.co.uk
Product
Service
Product
Service
EC Certificate
EC Certificate
Full Quality Assurance
System
Full Quality Assurance
System
Directive 93/42/EEC
on Medical
Devices
(MDD), Annex
ll excluding
(4)
Directive 93/42/EEC
on Medical
Devices
(MDD), Annex
l excluding (4)
(Devices
in Class
(Devices
in Class Illa, llb or ll)
No.
G1 15 09 93084 002
No.
G1 15 09 93084 002
Facility(ies):
Hadeco,
Inc.
Manufacturer
Hadeco,
Inc.
2-7.
-11 Arima, Miyamae-ku,
Kawasaki-shi
2-7-11 Arima, Miyamae-ku
Kanagawa,
216-0003 JAPAN
Kawasaki-shi, Kanagawa
216-0003 JAPAN
EC-Representative
ICHIYAMA GmbH
Benderstrale
130
40625 DisseIdorf
GERMANY
Product
Medical Ultrasonic Dopplers
Fetal Heart Beat Detectors
Category(ies)
Blood Flow and Blood
Velocity Meters
The Certification Body of TUv SUD
Product
Service GmbH
declares
that the aforementioned
manufacturer
has implernented
a quality assurance
system
for design, manufacture
and final
inspection
of the respective
devices
/ device categories
in accordance
with MDD
Annex
Il
This quality assurance
system
conforms
to the requirements
of this Directive
and is subject
to
periodical
surveillance.
For marketing
of class Ill devices
an
additional
Annex
is mandatory.
See also notes
overleaf.
JAQ235020810
Report No.:
2018-01-01
Valid from
2020-12-31
Valid until
05276822
188
Date,
2015-12- -18
Hans-Heiner
Junker
TOV
SOD
Product
Service GmbH
is Notified Body with identification
no. 0123
Page
2 of 2
Page
1 of 2
7
TI
TOv suo Product Service GmbH
Zertifizierstelle-
65 - 80339 Minchen
- Germany
Praduct Service GmbH
Zertifizierstelle Ridlerstrake 65 - 80339 Minchen
Germany
Product Service
CE RTIFI CATE No. Q1N 15 09 93084 001
Hadeco, Inc Holder of Certificate
2-7. -11 Arima, Miyamae-ku 3Hadeco Kawasaki- -shi, Kanagawa
216-0003 JAPAN
Facility(ies) Hadeco, Inc
2-7- -11 Arima, Miyamae-ku
Kawasaki-shi, Kanagawa, 216-0003 JAPAN
Certification Mark
Scope of Certificate: Design and Development, Production
Servicing and Distribution of
Medical Ultrasonic Dopplers
Fetal Heart Beat Detectors
Blood Flow and Blood Velocity Meters
Applied EN ISO 13485:2012 + AC:2012
Standard(s) Medical devices - - Quality management systems
Requirements for regulatory purposes
(ISO 13485:2003 + Cor. 1:2009)
DIN EN ISO 13485:2012
The Certification Body of TOV SUD Product Service GmbH certifies that the company mentioned
above has established and is maintaining a quality management system, which meets the
requirements of the listed standard(s). See also notes overileaf.
Report No JAQ235020810
Valid from 2016-01-01
Valid until 2018-12-31
94062768721853 Date, 2015-12-18
Hans-Heiner Junker
Page 1 of 1
Deutsche C
Akkreditierungssteile
D-ZM-11321-02-00 V)
Product Service GmbH Zertifizierstelle RidlerstralSe 65 - 80339 Minchen TUV Germany
