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sHANcHAt DocHEMtNDUsTRtES co.,LTD.
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suite 270144, No.7,Fu Ll Building,Lane i306, Jiang Ning Road,shanghai,chlna
Tel: 0086-2142774584;6276926b;
62769367 Fax: 0086-21-O2ZOOSSO
E-mail:info@dochem.biz dochem@sh163.comwebsite: www.dochem,biz

$ated: July 18,2016

To: Whom it may concern

LETTER
OFAPPOINTMENT

fhe undersigned,

SHANGHAIDOCHEMINDUSTRIES
CO.,LTD.,Suite2701-04,NO.7,Fu Li building,Lane1300, JiangNing
o:ad.5hanghai,China

Herebyappointsand authorises:

PT.COBRADENTALINDONESIA, a limited partnershipcompanyorganisedand existingunder the laws

of the lepublicof Indonesia,with legaldomicilein yogyakarta,lndonesia("cobra,,)

As an authorised Distributor of SHANGHAIDOCHEMINDUSTRTES

CO., LTD.,brands and products for
the salesregionof the entire Republicof lndonesia

'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

To:Whom it may concern

LETTE
ROFAUTHORIZATION

Dated: 18thof July,2016

TirelndoneslanHealthDepartment
Jakarta- Indonesia

We, SHANGI{AIDOCHEMINDUSTRIES CO.,LTD.Suite27OL-04, NO.7, Fu Li building,Lane1305Jiang

NingRoad, Shanghai,
China.Herebyauthorize
our agentin Indonesia:

PT.COBRA DENTAL INDONESIA

Pakuningratan
69,str
i;:eyakarta
55233,Indonesia

Toregisterour productswith the lndonesian

HealthDepartment
in Jakarta
for andbehalfof SHANGHAI
DOCHEM TNDUSTRTES CO.,LTD.

SHANGHAIDOCHEMINDUSTRIES
CO.,LTD.
By:
Name:Mr. Dou Han Bing
Title:GeneralManager
 A.
TUVRheinland

Certificate
The CertificationBody of
rUv RheinlandLGA ProductsGmbH

herebycertifiesthat the organization

Shanqhai Dochem
Industiies Go., Ltd.
Suite 7O5, No. 7, fuli Buildinq
-
Lane 1306 Jianq Ninq Road
Shanghai/OOoGb
China

has establishedand appliesa qualitymanagement systemfor medicaldevices

for the followingscope:

{see attachment for scope included}

Proofhas beenfurnishedthat the requirements

specifiedin

EN ISO 13485:2003+ AC:2009

are fulfilled.The qualitymanagement
systemis subjectto yearlysurveillance.

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

tUV nneinlandLGAProductsGmbH- TillystraBe2 - 90?Sfi berg

Tel.:+49221806-1371Fax:+49221 80S3935 e-mail.cert-validity@de.tuv.com
http://www.tuv.com/safety
 A.
TUVRheinland

Doc. I/I, Rev. 0

TUV Rheinland
LGA ProductsGmbH
Tillystraf3e2 , 9 0 4 3 1 N i i r n b e r g

Attachment to
Registration No.: sx 600779530001
Report No.: 1 5 0 4 9 5 1 90 0 1

Organization: Shanghai Dochem

Industries Co., Ltd.
Suite 7O5, No. 7, Fuli Building
L a n e 1 3 0 6 Jiang Ning Road
Shanghai 200060
Ghina

Scope: Design and Development. Manufacture and Distribution of

SLeam St,erilizers, Medical Oiode Laser SysEems;
Manufacture and Distribution of Disposable Syringes, Sterile
Dental Needles for Single Use, Root Canal(Endodontic) Files,
Absorbent Paper Point,s, GuLt,a Percha Polnts, t{igh-speed Air
Turbine Handpieces for Single Use, Synthetic Polymer TeeLh
Series, Dental Cements Series, Handpiece Tip, Rotary Dental
Polishing InsLruments, Ultrasonic Scaler, LighL Curing
DenLal Composite Resins, Root Canal- Post, Disposable Dental
Suction Tips, Disposable Dental 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, Dental Cottoir Rolls, Gauze Sponges, Cotton Tip
Applicators, Non-woven Swabs, Non-woven Surgical Gowns,
Face Masks, Non-woven Caps, Alcohol Swabs, Surgical
Operational KiLs,Disposable Oral Cavity Kits and Implements,
Dental Curing Light Units, Dental Alginate Impression
Materials, Shoe Covers, Dental Alginate Mixer, Dentel
Impressi-on Tray, Sterilization Pouch/Reets/Tape/fndicator
-- x rl x--., Akkreditiert
durch
i--
t+
Zentralstelle der Ldnder
Certification Body
* EL($'i'u'o?'J$i'l'.;:li:li
't .)'l und Medizinproduhlen
**
* *.* zlc-ze-995.00.0146

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

has establishedand appliesa qualitymanagementsystem

for the followingscope:

{see attachment for scope includedl

Proofhas beenfurnishedthat the requirements

specifiedin

EN ISO 9001:20O8
are fulfilled.The qualitymanagement
systemis subjectto yearlysurveillance.

CertificateRegistration
No.: SY 600779540001

An auditwas performed.
ReportNo.: 15049519
001

This Certificateis validuntil: 16.07.2017

Body
Certification

Date 10.08.2012

tUV nneinlandLGAProductsGmbH- TillystraBe2 - 90431Niirnberg

Tel.:+49221806-1371Fax:+49 221806-3935e-mail:cert-validily@de.tuv.com
hftp:/lwww.tuv.com/safety
 Doc. t/!, Rev. 0
TUV Rheinland
LGA ProductsGmbH
TillystrafSe2, 90431 Niirnberg

Attachment to
Registration No.: sY 600779540001
Report No.: 1 5 0 4 9 5 1 90 0 1

Organization: Shanghai Dochem

Industries Co., Ltd.
Suite 705, No. 7, Fuli Building
Lane 1306 Jiang Ning Road
Shanghai 200060
Ghina

."Scope: Design and Development, Manufacture and Distribution of

Steam Sterilizers, Medical Diode Laser Systems,-
Manufacture and Distribution of Disposable Syringes, Sterile
Dental Needles for Single Use, Root Canal (Endodontic) Files,
AbsorbenL Paper Points, Gutta Percha Points, High-speed Air
Turbine Handpieces for Sing1e Use, Synthetic Polymer Teeth
Series, Dental Cements Series, Handpiece Tip. Rotary DentaL
Polishing Instruments, Ultrasonic Scaler, Light Curing
Dental Composite Resins, Root -Canal Post, Oisposable Dental
Suction Tips, Disposable Dental Syringe Tips, Disposable
Dentsal Saliva Ejectors, Disposable Dental prophy Cups,
Disposable Denta1 Prophy Brushes, Disposable Denta1 Prophy
Ang1es, Chair Mounted Dental Unit, High and Low Speed
Turbine, Dental Cotto'n Rol-Is, Gauze Sponges, Cotton Tip
Applicators, Non-woven Swabs, Non-woven Surgical Gowns,
Face Masks, Non-woven Caps, Alcohol Swabs, Surgical
Operational Kits,Disposable Oral Cavity Kits and Implements,
Shoe Covers

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

RegistrationNo.: HD 6007795' , 0001

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

Products: Steam Sterilizers

Medical- Piode r,aser Systems

^ i

Expiry Date: 2017-07-r.6

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.

Effective Date: 2012-08-10

Date: 2012-08-10

TUV RheinlandLGA ProductsGmbH - Tillyst - 90431 Niirnberg

tUV RneinlandLGA Products GmbH is a Notified Body accordingto Directive 93/42|EEC

concerningmedicaldeviceswith the identificationnumber 0197.
 EC Certificate
A.
TUVRheinland
Directive 93l42lEEG Annex V
ProductionO,ualityAssurance
Medical Devices
't

RegistrationNo.: DD 60077952 0001

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

Products: Medical Devices

(see attachment for products included)

Replaces Approval, Registration No.: DD 6001-81-85 0001

Expiry Date: 20L7 -O7 -L6

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.

Effective Date: 2012-08*1_0

Date: 2012-08-1-0

TUV RheinlandLGA ProductsGmbH - - 90431 Ntirnberg

TUV RfreinlandLGA Products GmbH is a Notified Body accordingto Directive 93l42lEEC

concerningmedicaldeviceswith the identificationnumber 0197.
 . l
'L
- _-r.

. . @
TUVRheinland

Doc. l/2, Rev. 0

TUV Rheinland
LGA Products GmbH
Tillystrafie 2, 90431 Nfirnberg

Attachment to
Gertificate
Registration N o . : DD 60077952 0001
Report No.: 1 5 0 4 9 5 1 9 001

Manufacturer: Shanghai Dochem

Industries Go., Ltd.
Suite 7O5, No. 7, Fuli Building
Lane 1306 Jiang Ning Road
Shanghai 200060
China

,.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
l.
.-
I I

- ..
-
t r r.
--R
iIF\
@
TUVRheinland

Doc. 2/2, Rev. 0

TUV Rheinland
LGA Products GmbH
TiffystraBe2,'90431 Ntirnberg

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

",For the following medical devices the scope covers only

.,! the.laspects of manufacture concerned with securing and .,
maintaining sterile condition:

- Dental cotton Rolls

- Gauze Sponges
- Cobton Tip Applicators
- Non-woven Swabs
- Non-woven Surgical Gowns
- Face Masks
- Non-woven Caps
- Alcohol Swabs
- Surgical Operational Kits
- Disposable OraL Cavity Kits and Implenients

Date: 2012-08-10
ShanghaiDochemlndustriesCo.,Ltd. CE TechniqueDocument

EC Declarationof Conformity

lu{antfacturer: .,1.,
ShanghaiDochemIndustriesCo.,lrtd.,
Sulte 706,No.7,FU LlBuilding, Lane 1306
Jiang Ning Road, Shanghai,China
:
whosesingleAuthorizedRepresentative
Wellkang Ltd Ua Wellkang Tech Consulting
Suite B,29 Harley Qtreet LONDONWIG
9QR England, United Kingdom

We,the manufacturer,herewithdeclarethat the products

Dental bibs
SIZE: 13"x18":

UMDNS-Code;,|0-382

meetthe provisionsof Directive93l42tEECwhich applyto them.

The medicaldevicehasbeenassignedto class I accordingto AnnexIX of the Directive g3/42lEEC.

It bearsthe mark

( (

The product concernedhas been manufactured under a quality managementsystem according to

AnnexVf l of Directive93l42lEEC.

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.

The abovementioneddeclarationof conformityis exclusivelyunderthe responsibilityof

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

herewithdeclarethat the products

We,the manufacturer,
Dental bibs
SIZE: 13"x{8":

UMDNS-Code;{0-382

meetthe provisionsof Directive93l42lEECwhich applyto them.

The medicaldevicehasbeenassignedto class I accordingto Annex IX of the Directive 13142/EEC.

It bearsthe mark

The product concernedhas been manufacturedunder a quality managementsystemaccordingto

AnnexVll of Directive93l42lEEC.

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