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STANDARD E TB-Feron ELISA - Indonesia BPOM Medical Device Registration

STANDARD E TB-Feron ELISA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303817158. The device is manufactured by SD BIOSENSOR from Korea, Democratic People's Republic Of, and is classified as Risk Class Kelas Resiko : C. 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 : C
STANDARD E TB-Feron ELISA
Analysis ID: AKL 20303817158

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

SD BIOSENSOR

Country of Origin

Korea, Democratic People's Republic Of

Authorized Representative

PT. STANDARD BIOSENSOR INDONESIA

AR Address

LรVENUE OFFICE TOWER 21st Floor, Unit C Jl. Raya Pasar Minggu Kav. 16 Pancoran

Registration Date

Oct 10, 2018

Expiry Date

Dec 30, 2023

Product Type

Serological Reagents

Mycobacterium tuberculosis immunofluorescent reagents.

Invitro Diagnostics

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