GCare Glucose Control Solution - Indonesia BPOM Medical Device Registration

GCare Glucose Control Solution is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323768. The device is manufactured by GC MEDICAL SCIENCE CORP. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. GANDASARI EKASATYA.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

Powered by Pure Global AI

BPOM Registered

Risk Class Kelas Resiko : B

GCare Glucose Control Solution

Analysis ID: AKL 20101323768

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

GC MEDICAL SCIENCE CORP.

Country of Origin

Korea

Authorized Representative

PT. GANDASARI EKASATYA

AR Address

Jl. Raya HANKAM No.9A RT.007/002 Kel. Bambu Apus, Kec. Cipayung 13890

Registration Date

Sep 02, 2023

Expiry Date

Aug 31, 2025

Product Type

Clinical Chemistry Test System

Quality control material (assayed and unassayed) (cair)

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Other Products from GC MEDICAL SCIENCE CORP.

Products from the same manufacturer (5 products)

GREENCARE LIPID Profile Test Strip

Kelas Resiko : B

GREENCARE LIPID

Kelas Resiko : C

GCare Lipid Control Solution

Kelas Resiko : B

GCare Glucose Test Strip

Kelas Resiko : C

GCare Lipid

Kelas Resiko : C

Other Products from PT. GANDASARI EKASATYA

Products with the same authorized representative (10 products)

COPAN MSwab

COPAN ITALIA S.P.A

Kelas Resiko : A

NIHON PER Hemolynac-310

NIHON KOHDEN TOMIOKA CORPORATION

Kelas Resiko : B

NIHON PER Isotonac 3 Diluent

NIHON KOHDEN TOMIOKA CORPORATION

Kelas Resiko : B

NIHON KOHDEN MEK-680 Hemolynac 3N Lysing Reagent

NIHON KOHDEN TOMIOKA CORPORATION

Kelas Resiko : B

CELLTAC α+ AUTOMATED HEMATOLOGY AND ESR ANALYZER MEK-1305 and Accessories

NIHON KOHDEN TOMIOKA CORPORATION

Kelas Resiko : B

CELLTACα AUTOMATED HEMATOLOGY ANALYZER MEK-1302 and Accessories

NIHON KOHDEN TOMIOKA CORPORATION

Kelas Resiko : B

NIHON KOHDEN Automated Hematology Analyzer MEK-1301 Celltac α and Accessories

NIHON KOHDEN TOMIOKA CORPORATION

Kelas Resiko : B

CELLTAC G+ Automated Hematology Analyzer MEK-9200 and Accessories

NIHON KOHDEN TOMIOKA CORPORATION TOMIOKA PRODUCTION CENTER AND TOMIOKA OFFICE

Kelas Resiko : B

NIHON PER Hemolynac - 510

NIHON KOHDEN TOMIOKA CORPORATION.

Kelas Resiko : B

NIHON PER Reticulonac MK-110W

NIHON KOHDEN TOMIOKA CORPORATION

Kelas Resiko : A