TERRAGENE Self-Contained Biological Indicator - Indonesia BPOM Medical Device Registration

TERRAGENE Self-Contained Biological Indicator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20901026354. 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. SURGIKA ALKESINDO.

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

TERRAGENE Self-Contained Biological Indicator

Analysis ID: AKL 20901026354

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

Country of Origin

Argentina

Authorized Representative

PT. SURGIKA ALKESINDO

AR Address

Jl. Letjen Suprapto No.60, Gedung Indra Sentral unit G-H, Cempaka Putih

Registration Date

Jun 14, 2022

Expiry Date

Mar 18, 2024

Product Type

General and Individual Hospital Equipment Monitoring

Sterilization process indicator.

Non Electromedic Non Sterile

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Similar Products (1)

Other products with the same name

TERRAGENE Self-Contained Biological Indicator

TERRAGENE S.A.

Kelas Resiko : B

Other Products from TERRAGENE S.A

Products from the same manufacturer (10 products)

BIONOVA MiniPro Incubator with Automatic Readout Systems

Kelas Resiko : B

BIONOVA Auto-reader Incubator IC10/20FR

Kelas Resiko : B

BIONOVA Auto-reader Incubator Minibio

Kelas Resiko : B

BIONOVA Biological Indicator BT96

Kelas Resiko : B

CHEMDYE Cleaning Indicator

Kelas Resiko : B

BIONOVA Biological Indicator BT110

Kelas Resiko : B

BIONOVA Biological Indicator BT224

Kelas Resiko : B

CHEMDYE Chemical Indicator

Kelas Resiko : B

CHEMDYE Splat Cleaning Indicator

Kelas Resiko : B

BIONOVA Biological Indicator

Kelas Resiko : B

Other Products from PT. SURGIKA ALKESINDO

Products with the same authorized representative (10 products)

IDS Fractional CO2 Laser

IDS LTD.

Kelas Resiko : C

HAAG-STREIT Operating Microscope

HAAG-STREIT AG

Kelas Resiko : A

NOPA Neuro Surgery Set

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Kelas Resiko : A

SCHMITZ Examination and Treatment Chair Arco

SCHMITZ MEDICAL GMBH.

Kelas Resiko : B

HYDROCYN aqua Solution

BACTIGUARD (SOUTH EAST ASIA) SDN.BHD.

Kelas Resiko : B

RADIOBLATOR RF4

RICHARD WOLF GMBH

Kelas Resiko : C

HYDROCYN Aqua Wound Prep Absorbent Gauze

BACTIGUARD (SOUTH EAST ASIA) SDN.BHD.

Kelas Resiko : A

IDS Picosecond Nd:YAG Laser

IDS LTD.

Kelas Resiko : C

ATMOS ENT Treatment System

ATMOS MEDIZINTECHNIK GMBH. & CO., KG.

Kelas Resiko : A

NOPA Pediatric Surgery Set

NOPA INSTRUMENTS MEDIZINTECHNIK GMBH

Kelas Resiko : A