I(EMENTERIAN I(ESEIIATAN .

REPUBLII( INDONESIA
DIREKTORAT JENDERAL I(EFARN4ASIAN DAN ALAT I(ESEHATAN
DIREKTORAT PENGAWASAN ALAT KESEI{ATAN DAN PKRT
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SERTHP'IKAT
A CERTfT{CATE
CARA PEMBUATAN ALAT KESEHATAN YANG BAIK
GOOD 144NL.(;A{'T{/PJI,{C PLAL-TICE FOR MEDICAI. DETICES

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Diberikan kepada
Prcsenled ta
PT. SINKO PRIMA ALLOY
Tambak Osowilangon Permai E7 - 8, Surabaya

Telah memeaehi sy&rat untuk merdapatkan

Sertifikat Cara Pembuatan Alat Kesehatan yang Baik
Has bee* approved to get Cert'trtcatu af Good Manufacturing Practice for Medical Deviees

Ruang lingkup
Scope

Produksi Peralatan Telinga, Hidung dan Tenggorokan : Sinus

lrrigator/Powered Nasal Irrigator, Hearing Aid ; Peralatan Obstetrik dan
Ginekologi : USG Gel, Fetal Monitor, Fetal Stethoscope, Fetal Cardiac
Monitor, Maternal Fetal Monitor, Obstetric Chair, USG Monitor, Fetal
Doppler, USG, Breast Pump ; Peralatan Kesehatan Fisik : Flotation
Cushion, Bathroom Aid & Safety, Daily Activity Asist Device,
WalkeriWalking Aid, Crutch, Cane, Rollator, Commode Chair, Wheel
Chair, Exercise Equipment, Cold or Hot Pack, Traction Equipment,
Powered Heating Unit, Infrared Lamp, Powered Heating Pad ; Peralatan
Radiologi : Ultrasonic Medical Image Workstation, Tele radiologi, USG
Monitor

A.n Direktur Jenderal

Direktur PengawasanAlat Kesehatan dan PKRT
Thnggal Persetujuan
On Behalf of Director General
Apprct,al Dale
Director of Post Market Control of Medical Devices
I I oCT 20t6 and Household Product

Berlaku hingga
l/alicl thru

II oCT 2021
lll"Kes.
t".+,$W 3 1986031004