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STANDARD™ Q HCV Ab Test - Indonesia BPOM Medical Device Registration

STANDARD™ Q HCV Ab Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305913621. The device is manufactured by SD BIOSENSOR INC. from Korea, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. STANDARD BIOSENSOR INDONESIA.

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 : D
STANDARD™ Q HCV Ab Test
Analysis ID: AKL 30305913621

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

SD BIOSENSOR INC.

Country of Origin

Korea

Authorized Representative

PT. STANDARD BIOSENSOR INDONESIA

AR Address

L'AVENUE BUILDING UNIT C, LT. 21, JL. RAYA PASAR MINGGU KAV. 16

Registration Date

Oct 10, 2024

Expiry Date

Jan 18, 2029

Product Type

Immunological Test System

Antinuclear antibody immunological test system.

Invitro Diagnostics

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