KEMILO D-Dimer Kit and Accessories - Indonesia BPOM Medical Device Registration

KEMILO D-Dimer Kit and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221481. The device is manufactured by GOLDSITE DIAGNOSTICS INC from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. SUMIFIN CITRA ABADI.

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 : C

KEMILO D-Dimer Kit and Accessories

Analysis ID: AKL 20101221481

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

GOLDSITE DIAGNOSTICS INC

Country of Origin

China

Authorized Representative

PT. SUMIFIN CITRA ABADI

AR Address

Jl. Alam Sutera Boulevard Alam Sutera Town Center (ASTC) Blok 10D No.19, Kel. Pakulonan, Kec. Serpong Utara - Tangerang Selatan 15325

Registration Date

Apr 28, 2023

Expiry Date

May 16, 2025

Product Type

Clinical Chemistry Test System

Multi parameter clinical chemistry test system

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Other Products from GOLDSITE DIAGNOSTICS INC

Products from the same manufacturer (6 products)

GOLDSITE Kemilo 25-OH-VD Kit

Kelas Resiko : B

GOLDSITE Kemilo NT-ProBNP Kit

Kelas Resiko : B

GOLDSITE Kemilo Tβ-HCG Kit

Kelas Resiko : B

GOLDSITE Kemilo TSH Kit

Kelas Resiko : B

KEMILO cTnl Kit

Kelas Resiko : B

KEMILO Prog Kit

Kelas Resiko : B

Other Products from PT. SUMIFIN CITRA ABADI

Products with the same authorized representative (10 products)

DIAFIN DFRC-24A Refrigerated Centrifuge

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Kelas Resiko : A

DIAFIN DFLC-22 Low Speed Centrifuge

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Kelas Resiko : C

DIAFIN DFLC-30 Clinical Centrifuge

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Kelas Resiko : A

ZENIX Glycated Hemoglobin Test kit (HPLC)

SHENZHEN XILAIHENG MEDICAL ELECTRONICS CO., LTD.

Kelas Resiko : B

DIAFIN DFRC-12A Refrigerated Centrifuge

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Kelas Resiko : A

DIAFIN DFRC-12B Refrigerated Centrifuge and Accessories

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Kelas Resiko : B

INNODX TSH CMIA

XIAMEN INNODX BIOTECH CO., LTD.

Kelas Resiko : B

ZELL-ESR Erythrocyte Sedimentation Rate Analyzer

STERILE SAFEQUIP AND CHEMICALS LLP

Kelas Resiko : A

KEWEI RV-IgM Test Kit

BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC

Kelas Resiko : C

DIAFIN DFGC-23 Blood Gel Cards Centrifuge

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Kelas Resiko : C