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ANSWER Syphilis Ab Combo Rapid Test - Indonesia BPOM Medical Device Registration

ANSWER Syphilis Ab Combo Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303817157. The device is manufactured by CTK BIOTECH., INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. EXXEL MAIN.

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 : C
ANSWER Syphilis Ab Combo Rapid Test
Analysis ID: AKL 20303817157

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

CTK BIOTECH., INC.

Country of Origin

United States

Authorized Representative

PT. EXXEL MAIN

AR Address

JALAN RAJAWALI SELATAN.RUKO MULTI GUNA KEMAYORAN BLOK.6N.JAKARTA UTARA

Registration Date

Nov 08, 2021

Expiry Date

Nov 08, 2024

Product Type

Serological Reagents

Treponema pallidum treponemal test reagents.

Invitro Diagnostics

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