EPOC™ HOST 2 and accessories - Indonesia BPOM Medical Device Registration

EPOC™ HOST 2 and accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101025547. The device is manufactured by EPOCAL INC. from Canada, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SIEMENS HEALTHINEERS INDONESIA.

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

EPOC™ HOST 2 and accessories

Analysis ID: AKL 20101025547

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

Country of Origin

Canada

Authorized Representative

PT. SIEMENS HEALTHINEERS INDONESIA

AR Address

Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl. Tahi Bonar Simatupang Kav. 88, Kel. Kebagusan, Kec. Pasar Minggu, Jakarta Selatan, DKI Jakarta

Registration Date

Sep 22, 2020

Expiry Date

Apr 06, 2025

Product Type

Clinical Chemistry Test System

Blood gases (P CO 2, P O 2) and blood pH test system

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Other Products from EPOCAL INC.

Products from the same manufacturer (5 products)

EPOC Reader Blood Analysis

Kelas Resiko : B

EPOC Blood Analysis BGEM Test Card

Kelas Resiko : B

EPOC Reader AP Blood Analysis

Kelas Resiko : B

EPOC BGEM Test Cards

Kelas Resiko : C

EPOC Host Blood Analysis (EPOC Host 2) and Accessories

Kelas Resiko : B

Other Products from PT. SIEMENS HEALTHINEERS INDONESIA

Products with the same authorized representative (10 products)

ADVIA Centaur Calibrator D

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Kelas Resiko : B

DIMENSION Revised C-Reactive Protein Calibrator (RCRP CAL)

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Kelas Resiko : B

IMMULITE 2000 Systems Allergen Specific IgE Universal Kit

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Kelas Resiko : B

IMMULITE 2000 3gAllergy Specific IgE Positive Control for D1 &D2

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Kelas Resiko : B

ADVIA Centaur Anti-HBs2 Quality Control (aHBs2 QC)

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Kelas Resiko : B

DIMENSION Bilirubin Calibrator (TBI/DBI CAL)

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Kelas Resiko : B

ADVIA Centaur CA 15-3

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Kelas Resiko : C

ADVIA Centaur Insulin (IRI)

MINARIS MEDICAL CO., LTD.

Kelas Resiko : B

CLINITEK Status+ Analyzer and Accessories

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.

Kelas Resiko : B

DIMENSION Tacrolimus Calibrator

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Kelas Resiko : B