Pure Global

EGENS Diagnostic Kit for Treponema Pallidum, Cassette - Indonesia BPOM Medical Device Registration

EGENS Diagnostic Kit for Treponema Pallidum, Cassette is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303321407. The device is manufactured by NANTONG EGENS BIOTECHNOLOGY CO., LTD., CHINA from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is SARANA KARYA MEDIKA.

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
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : C
EGENS Diagnostic Kit for Treponema Pallidum, Cassette
Analysis ID: AKL 20303321407

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

SARANA KARYA MEDIKA

AR Address

UBUD VILLAGE BLOK KINTAMANI C1 NO.15 KEL.SUDIMARA TIMUR

Registration Date

Sep 13, 2023

Expiry Date

Jun 01, 2028

Product Type

Serological Reagents

Treponema pallidum treponemal test reagents.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing