Laboratory Automation System SATLARS™ T8 - Indonesia BPOM Medical Device Registration

Laboratory Automation System SATLARS™ T8 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102520084. The device is manufactured by SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SNIBE DIAGNOSTIC INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : B

Laboratory Automation System SATLARS™ T8

Analysis ID: AKL 20102520084

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.

Country of Origin

China

Authorized Representative

PT. SNIBE DIAGNOSTIC INDONESIA

AR Address

TEMPO SCAN TOWER, LANTAI 21, JALAN H.R. RASUNA SAID KAV. 3-4

Registration Date

Feb 12, 2025

Expiry Date

Oct 30, 2029

Product Type

Clinical Laboratory Equipment

Instrumentation for clinical multiplex test systems.

Invitro Diagnostics

DJ Fang

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Laboratory Automation System SATLARS™ T8 - Indonesia BPOM Medical Device Registration

Risk Classification

Product Class

Manufacturer

Country of Origin

Authorized Representative

AR Address

Registration Date

Expiry Date

Product Type

DJ Fang

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MAGLUMI Anti-Cardiolipin IgG (CLIA)

MAGLUMI Anti-Cardiolipin (CLIA)

MAGLUMI Anti-Cardiolipin IgM (CLIA)

MAGLUMI Anti-β2-Glycoprotein 1 IgM (CLIA)

MAGLUMI Anti-β2-Glycoprotein 1 IgG (CLIA)

MAGLUMI Anti-Cardiolipin IgA (CLIA)

MAGLUMI AMH (CLIA)