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SM ALP Reagent Kit - Indonesia BPOM Medical Device Registration

SM ALP Reagent Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421382. The device is manufactured by URIT MEDICAL ELECTRONIC CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FAITHFUL MEDICAL GRACE.

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.

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BPOM Registered
Risk Class Kelas Resiko : B
SM ALP Reagent Kit
Analysis ID: AKL 20101421382

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. FAITHFUL MEDICAL GRACE

AR Address

Mitra Sunter Boulevard Blok B No. 39, Jl. Yos Sudarso Kav. 89 Kel. Sunter Jaya, Kec. Tanjung Priok, Jakarta Utara

Registration Date

Jul 29, 2024

Expiry Date

Jul 23, 2027

Product Type

Clinical Chemistry Test System

Alkaline phosphatase or isoenzymes test system (kit & cair)

Invitro Diagnostics

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