EURoGL€aBALcERTlFlcATloNs (uK) LTD,

Certificate of ComPlianceWe hereby declare that the technical file of

IVIARUTI MEDITECH PRIVATE LIMITED

13To48,22AI{D2S,BYPASSTHANAROAD-,MIRCHIBILA.\\-.{.\anPATNA-SOOOOg, BIHAR (INDIA

hasbeenassessed&foundtobeinconformancewiththeprovisionssetforthbythe requirement of Directive Medical Devices Directive g3t4zlEEC (MDD) Class l"

PRoDucTDESCRIPTIeil;iffi.BB3tTlg3#Iii1".ffi SyINGES',NEEDLES

Thecertificationbodyhasperformedasampleauditoftheaboveproductquality.systemcoveringthedesign man.'a::'-ei=-:--':=-

of the certified product(s). rn" qr"r,tv system has n""n "lJJtJoi 'ppt*"0 ano ii suuiect to continLrous suTve'liar': z'::- -

= - =-

Medicat DevicesDirectivesi/ai[;diriijolcrrrrt.-uoiooitionar testreport*"t"t'i'"doutfromsubmrttedivpesa-:::':-::--:--'-

"onforriti'i,',tn-il;58;";ti* ottn"i"tp""ii".iianciatOs except those submitted bv the Custon''e'

Certificate No.

Date of Initial Registration

7" Sunteillance on or before

2"0 Surveillance on or before

EU5838

23"d APriI 2019

23'd APrii 2020

23'd APriI 2021

Issue Date 23'c \Pnr i ' - '

Expiry Date 22'c \Pnl i - - -

Authorized SignatorY(€

The certificate is the property of EUR0GLOBAL CERTIFICATI0NS (UK) LIMITED and shall be returned immediately on IequES:

Registered gffice : lst Floor, 2 Woodbeny Grove, Finchley, London, N12 gDR' UNITED KINGDSM

Website : www. euroglobal'uk'com

aEtrr i-:r:

The Registration is not a Product Ouality Certificate*Subject to successful comPletion of surveillanc' audits

. Visit for verifi€tiotr on ff.*odoad *"cn

tIIl-

IJJ

CJ g..rBl

/oZ---YJs-iEurO\csl-- lx2\ Global i^\Ux'62

GIO[flIAssessment

- -_ "l.ot'((-orlil\'"

-

C@oSfumplianmIssued to:

MARUTI MEDITECH PVT. LTD.Carried out at following site:

OFFICE : 1 & 2, GROUND FLOOR, VENKATESHAPARTMENT, BUDH MARG, PATNA - 800 001 (BTHAR)

(TNDIA)&

FACTORY : VILLAGE. MIRCHI BHAWANIA, BY PASSTHANA, PATNA - 800 009 (BTHAR) (INDTA)

for their:

MEDICAL DBVICES - QUALITY MANAGEMENT SYSTEMS

ISO 13485 z 2016

SCOPE of Activities covered by this Certificate:

MANUFACTURER & SUPPLIBR OF HYPODERMIC MEDICALDISPOSABLE SYRINGES AND IV SETS

Certificate no. : EAS./MD./BIOOElssued on : O4./O9^/2O18 1st Surveillance Due On : Q4.1AA,/2O19

.",1'.tltrT:"..:i,??:??!.1??.',.....,r.,r*r..rr.rr..3::.::Y."1".11??y:.?:.'...:,::?::?:.,"?..,The validity of certificate is subject to regular surveillance audit on or before above mentioned dates and it's

only valid after successful surveillance with continuation letter issued by GA

Aritho.ized Si$arato r',i

Gl$hal AsseEsmeEt

WWW.theglObalaSSeSSmgnt.COm rhisisffiutrisitecGrtification

Registered Office'- HU 1023 Budapest, Becsi ut 3-5. Hungary

The cedmcate remains trE property of Global Assessmsnt Kft and shall be retum€d imrnedialely upon request.

.*d;

Acc No.:. IUACl06

s

AWARDED TO

for their Premises at

Excel Management Certification certifies that the Management Systems of the above organization has been audited as per the guidelines of ISO 19011:2011 and IAF MD01 Documents are found to be in accordance with the requirement of the Management System as mention below:

ISO 14001 : 2015

Certificate No : EMC-EM

Date of Current Certificate : 21/09/2019

Date of Expiry of Certificate : 20/08/2022

1st Surveillance : Due on or Before : 21/09/2020

2nd Surveillance : Due on or Before : 21/09/2021

S-106709212019 Date of Original Certificate : 21/09/2019

This Certificate remains the Property of Excel Management Certifications and must be returned if Certificate is Withdrawn

Add.: Swami Shivam Complex, Sinhgad Road, Vadgaon Budruk, Pune- 411 041, Maharashtra (India)

The Verification mail is : enq@emcindia.org

Or you can verify it from on website : www.emcindia.org

TECHNICAL DIRECTOR MSCB.IN.M.0213

MARUTI MEDITECH PVT.LTD.

MANUFACTURER & SUPPLIER OF HYPODERMIC MEDICAL DISPOSABLE SYRINGES, NEEDLE AND IV SETS

OFFICE : 1&2 GROUND FLOOR, PUSHPANJALI VENKATESH APARTMENT, BUDH MARG, PATNA-800001, BIHAR (INDIA) FACTORY: VILLAGE- MIRCHI BHAWANIA, BY PASS THANA, PATNA-800009,BIHAR (INDIA)

R fo e get isa tc rif ait tir oe nC

Scope of Registration

ENVIRONMENT MANAGEMENT SYSTEMS