Pure Global

BIONOVA Biological Indicator - Indonesia BPOM Medical Device Registration

BIONOVA Biological Indicator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20901915610. The device is manufactured by TERRAGENE S.A. from Argentina, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INTISUMBER HASILSEMPURNA.

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 : B
BIONOVA Biological Indicator
Analysis ID: AKL 20901915610

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

TERRAGENE S.A.

Country of Origin

Argentina

Authorized Representative

PT. INTISUMBER HASILSEMPURNA

AR Address

KOMPLEK DARMO PARK II BLOK IV NO. 14-15 JL. MAYJEND SUNGKONO SURABAYA

Registration Date

Feb 16, 2022

Expiry Date

Dec 02, 2023

Product Type

General and Individual Hospital Equipment Monitoring

Sterilization process indicator.

Non Electromedic Non Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing