EPOC Blood Analysis BGEM Test Card - Indonesia BPOM Medical Device Registration

EPOC Blood Analysis BGEM Test Card is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221434. The device is manufactured by EPOCAL INC. from Canada, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is SIEMENS HEALTHINEERS INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : B

EPOC Blood Analysis BGEM Test Card

Analysis ID: AKL 20101221434

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

Country of Origin

Canada

Authorized Representative

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 06, 2022

Expiry Date

Apr 06, 2025

Product Type

Clinical Chemistry Test System

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

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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Other Products from EPOCAL INC.

Products from the same manufacturer (5 products)

EPOC Reader Blood Analysis

Kelas Resiko : B

EPOC Reader AP Blood Analysis

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EPOC BGEM Test Cards

Kelas Resiko : C

EPOC Host Blood Analysis (EPOC Host 2) and Accessories

Kelas Resiko : B

EPOC™ HOST 2 and accessories

Kelas Resiko : B

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