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HELMER iBF125-GX Plasma Freezer - Indonesia BPOM Medical Device Registration

HELMER iBF125-GX Plasma Freezer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209220153. The device is manufactured by HELMER INC from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is FRISMED HOSLAB 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 : B
HELMER iBF125-GX Plasma Freezer
Analysis ID: AKL 20209220153

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

HELMER INC

Country of Origin

United States

Authorized Representative

FRISMED HOSLAB INDONESIA

AR Address

Ruko Bidex Blok G No. 30-31 Jl. Pahlawan Seribu BSD City, 15321

Registration Date

May 16, 2023

Expiry Date

Dec 31, 2025

Product Type

Products used in the manufacture of blood preparations and preparations of origin and blood

Blood storage refrigerator and blood storage freezer.

Non Radiation Electromedics

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