RIGHTSIGN PSA Rapid Test Cassette (Whole Blood/Serum/Plasma) - Indonesia BPOM Medical Device Registration

RIGHTSIGN PSA Rapid Test Cassette (Whole Blood/Serum/Plasma) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306512681. The device is manufactured by HANGZHOU BIOTEST BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MACROCITRA ARDANASEJATI.

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.

Free Database

BPOM Registered

Risk Class Kelas Resiko : C

RIGHTSIGN PSA Rapid Test Cassette (Whole Blood/Serum/Plasma)

Analysis ID: AKL 20306512681

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

HANGZHOU BIOTEST BIOTECH CO., LTD.

Country of Origin

China

Authorized Representative

PT. MACROCITRA ARDANASEJATI

AR Address

Rukan Taman Meruya Blok M-65 Meruya Ilir - Jakarta Barat Telp. 021-5874575, Fax. 021-5874573

Registration Date

Nov 28, 2022

Expiry Date

Jun 10, 2025

Product Type

Tumor Antigen Immunologic Test System

Tumor-associated antigen immunological test system.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from HANGZHOU BIOTEST BIOTECH CO., LTD.

Products from the same manufacturer (10 products)

RIGHTSIGN PSA Rapid Test Cassette (Whole Blood/Serum/Plasma) - 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

RIGHTSIGN COC Rapid Test Strip (Urine) 300ng/mL

RIGHTSIGN COC Rapid Test Cassette (Urine) 300 ng/mL

RIGHTSIGN Typhoid Rapid Test Cassette (Serum/Plasma)

RIGHTSIGN BZO Rapid Test Cassette (Urine) 300 ng/ml

RIGHTSIGN HCV Rapid Test Cassette (Serum/Plasma)

RIGHTSIGN HBsAg Rapid Test Cassette (Serum/Plasma)

RIGHTSIGN AMP Rapid Test Cassette (Urine)

RIGHTSIGN Multi 3 Drugs Rapid Test Panel (Urine) (AMP1000/THC50/MOP300)

RIGHTSIGN THC Rapid Test Strip (Urine)

RIGHTSIGN THC Rapid Test Cassette (Urine)