LoA Dochem PDF
LoA Dochem PDF
LoA Dochem PDF
LETTER
OFAPPOINTMENT
fhe undersigned,
SHANGHAIDOCHEMINDUSTRIES
CO.,LTD.,Suite2701-04,NO.7,Fu Li building,Lane1300, JiangNing
o:ad.5hanghai,China
Herebyappointsand authorises:
'the
validityof this appointmentis for a period of Five {5) yearsfrom the date of this appointmentuntil
.,t1',1
L7,2O2!.
SHANGHAIDOCHEMINDUSTRIES
CO.,LTD.
By:
Name:Mr.DouHanBing
Title:GeneralM
'HANGHAT DocHEM rNDUsrRrEs
co..LrD.
IFAdd: F#E
suite 2701-04,
El===
No.7,Fu Ll Building,Lane'1306,
JiangNingRoad,
shanghai,china
Tef:0086-212774584;62769265;
62769367 Fax:0086-21-62766590
E'mail:info@dochem.biz
dochem@sh163.com
Webslte:www.dochem.biz
LETTE
ROFAUTHORIZATION
TirelndoneslanHealthDepartment
Jakarta- Indonesia
SHANGHAIDOCHEMINDUSTRIES
CO.,LTD.
By:
Name:Mr. Dou Han Bing
Title:GeneralManager
A.
TUVRheinland
Certificate
The CertificationBody of
rUv RheinlandLGA ProductsGmbH
Certificate
Registration
No.: sx 60077953
0001
An auditwasperformed.
ReportNo.: 15049519
001
ThisCertificate
is validuntil: 16.07.2017
Certification
Body
x*R** '.1r
Akkreditiertdurch
ZentralslellsderLSodet
*
" ESG ; "'o?:lxH':*:iHl;
X. .51 und Mcdizinprodukton
**
* ** zLc-zo-995.00.0146
Date 10,08.2012
Attachment to
Registration No.: sx 600779530001
Report No.: 1 5 0 4 9 5 1 90 0 1
Date: 2012-08-1O
A.
TUVRheinland
Gertificate
The Certification Body of
TUV Rheinland LGA Products GmbH
herebycertifies
thattheorganization
Shanqhai Dochem
Industiies Co., Ltd.
Suite 7O5, No. 7, tuli Building
Lane 13OOJianq Ninq Road
ShanghaiZbOOGb
China
EN ISO 9001:20O8
are fulfilled.The qualitymanagement
systemis subjectto yearlysurveillance.
CertificateRegistration
No.: SY 600779540001
An auditwas performed.
ReportNo.: 15049519
001
Date 10.08.2012
Attachment to
Registration No.: sY 600779540001
Report No.: 1 5 0 4 9 5 1 90 0 1
Certification Body
j .'
': l
i
: : I
Date: 2012-08-10
,{;
ut:!:rSrqte
EC Certificate
Directive 93l42lEEG Annex ll, excluding Section 4
Full O.ualityAssurance System
Medical Devices
ReportNo.: 1 5 0 4 9 5 1 90 0 1
Manufacturer: ShanghaiDochem.
IndustriesCo., Ltd.
Suite 7O5, No. 7, Fuli Building
Lane 13OGJiang Ning Road
Shanghai200060
Ghina
^ i
The Notified Body hereby declares that the requirements of Annex ll, excluding section 4 of the directive
93l42lEEC have been met lor the listed products. The above named manufacturer has established
and applies a quality assurance system, which is subject to periodic surveillance, defined by Annex ll,
section 5 of the aforementioned directive. For placing on the market of class lll devices covered by
this certificate an EG design-examination certificate according to Annex ll, section 4 is required.
Date: 2012-08-10
ReportNo.: 1 5 0 4 9 5 1 90 0 1
\,
Manufacturer: ShanghaiDochem.
IndustriesCo., Ltd.
Suite 7O5, No. 7, Fuli Building
Lane 1306 Jiang Ning Road
Shanghai200060
China
The Notified Body hereby declaresthat the requirementsof Annex V of the directive 93l42lEEC have
been met for the listed products. The above named manufacturerhas establishedand applies a quality
assurancesystem, which is subject to periodic surveillance.defiied by llnnex V, section 4 of the
aforementioneddirective. For placing on the market of class llb and class lll devices covered by this
certificate an EG type-examinationcertificateaccordingto Annex lll is required.
Date: 2012-08-1-0
. . @
TUVRheinland
Attachment to
Gertificate
Registration N o . : DD 60077952 0001
Report No.: 1 5 0 4 9 5 1 9 001
,.Products:
Disposable Syringes
St.erile Dent.al Needles for Single Use
Root Canal (Endodontic) Files
Absorbent Paper Points
Gutla Percha Points
High-speed Air Turbine Handpieces for Single
Synthetic Polymer Teeth Series
Dental Cements Series
Handpiece Tip
Rotary Dental Polishing Instruments
Ultrasonic Scaler
Light Curing Dental Composite Resins
Root Canal Post
Disposable Denta1 Suction Tips
Disposable Dent.al Syringe Tips
Disposable Dental Saliva Ejectors
Disposable Dental Prophy Cups
Disposable Dental Prophy Brushes
Disposable Dental Prophy Angles
Chair Mounted Dental Unit
High and Low Speed Turbine
Date: 2O12-08-1O
I
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iIF\
@
TUVRheinland
Attachment to
Gertificate \
RegistrationN o . : DD 60077952 0001
Report No.: 15049519 001
Manufacturet: ShanghaiDochem
IndustriesGo., Ltd.;
Suite 7O5, No. 7, Fuli Building
Lane 13OOJiang Nilg Road
Shanghai 200060
China
Date: 2012-08-10
ShanghaiDochemlndustriesCo.,Ltd. CE TechniqueDocument
EC Declarationof Conformity
lu{antfacturer: .,1., :
whosesingleAuthorizedRepresentative
ShanghaiDochemIndustriesCo.,lrtd., Wellkang Ltd Ua Wellkang Tech Consulting
Sulte 706,No.7,FU LlBuilding, Lane 1306 Suite B,29 Harley Qtreet LONDONWIG
Jiang Ning Road, Shanghai,China 9QR England, United Kingdom
UMDNS-Code;,|0-382
( (
following the procedurerelatingto the EC Declarationof Conformity set out in Annex VII coupled
rr.itlrAnnexV of Directive93|42/EEC
follorving the procedurerelatingto the EC Declarationof Conformity set out in Annex VII coupled
with AnnexV of Directive93l42lEEC.
ShanghaiDochemIndustriesCo.,Ltd.
Suite705,No.7,FULl Building,Lane1306JiangNingRoad,Shanghai,China
,'*
rry
DocumentNo: DIVCE-091-10 Edition / ModiS Case: A/1
ShanghaiDochemIndustries
Co.,Ltd. CETechnique
Document
EG Declarationof Conformity
Manufacturer: whosesingleAuthorizedRepresentative:
Shanghai Dochem Industries Co.,Ltd. ; Wellkang Ltd Ua Wellkang Tech Consulting
Suite 705,No.7,FU Ll Building,Lane 1306 Suite B, 29 Harley Street LONDONWlG
Jiang Ning Road,Shanghai,China 9QR England,United Kingdom
UMDNS-Code;{0-382
following the procedurerelatingto the EC Declarationof Conformity set out in Annex VII coupled
n itlr AturexV of Directive93|42/EEC
following the procedurerelatingto the EC Declarationof Conformityset out in Annex VII coupled
with AnnexV of Directive93l42lEEC.
The abovementioned
declaration
of conformityis exclusivelyunderthe responsibility
of
ShanghaiDochemlndustriesCo.,Ltd.
Suite705,No.7,FULl Building,Lane1306JiangNingRoad,Shanghai,
China
{rt* rq
DocumentNo: DH/CE-091-10 Edition / Modi$ Case: A/1