EUROIMMUN Leptin ELISA - Indonesia BPOM Medical Device Registration

EUROIMMUN Leptin ELISA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101125626. The device is manufactured by DIAGNOSTICS BIOCHEM CANADA INC. from Canada, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INTI MAKMUR MEDITAMA.

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BPOM Registered

Risk Class Kelas Resiko : B

EUROIMMUN Leptin ELISA

Analysis ID: AKL 20101125626

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

DIAGNOSTICS BIOCHEM CANADA INC.

Country of Origin

Canada

Authorized Representative

PT. INTI MAKMUR MEDITAMA

AR Address

Gandaria 8 Office Tower Lantai 16 Unit F Jl. Sultan Iskandar Muda No. 8 RT 010 RW 006

Registration Date

Jan 20, 2025

Expiry Date

Aug 30, 2028

Product Type

Clinical Chemistry Test System

Lipoprotein test system (kit & cair)

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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