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EDAN Test Cartridge iBG8-OXI pH,pCO2,pO2,Na+,K+,Cl-,Ca++,tHb,sO2,FO2Hb,FHHb,FCOHb,FMetHb - Indonesia BPOM Medical Device Registration

EDAN Test Cartridge iBG8-OXI pH,pCO2,pO2,Na+,K+,Cl-,Ca++,tHb,sO2,FO2Hb,FHHb,FCOHb,FMetHb is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421960. The device is manufactured by EDAN INSTRUMENT, INC., from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. NUSANTARA MEDCARE INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
EDAN Test Cartridge iBG8-OXI pH,pCO2,pO2,Na+,K+,Cl-,Ca++,tHb,sO2,FO2Hb,FHHb,FCOHb,FMetHb
Analysis ID: AKL 20101421960

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. NUSANTARA MEDCARE INDONESIA

AR Address

NUSANTARA MEDCARE INDONESIA

Registration Date

Oct 07, 2024

Expiry Date

May 09, 2028

Product Type

Clinical Chemistry Test System

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

Invitro Diagnostics

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