Pure Global

HEMATYPE Segment Device - Indonesia BPOM Medical Device Registration

HEMATYPE Segment Device is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10209714603. The device is manufactured by FENWAL INTERNATIONAL INC from Dominican, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. FRESENIUS KABI 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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : A
HEMATYPE Segment Device
Analysis ID: AKL 10209714603

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

Dominican

Authorized Representative

PT. FRESENIUS KABI INDONESIA

AR Address

Menara Bidakara 1 Lt.19, Jl. Gatot Subroto Kav 71 - 73 Menteng Dalam, Tebet, Jakarta Selatan 12870

Registration Date

Sep 17, 2021

Expiry Date

May 25, 2025

Product Type

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

Blood bank supplies.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing