Pure Global

AURORA Plasmapheresis System and Accessories - Indonesia BPOM Medical Device Registration

AURORA Plasmapheresis System and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209027396. The device is manufactured by FRESENIUS KABI WARRENDALE from United States, and is classified as Risk Class Kelas Resiko : B. 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 : B
AURORA Plasmapheresis System and Accessories
Analysis ID: AKL 20209027396

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. FRESENIUS KABI INDONESIA

AR Address

Menara Bidakara 1 Lt 19, Jl. Jend Gatot Subroto Kav 71-73

Registration Date

Sep 27, 2024

Expiry Date

Mar 07, 2028

Product Type

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

Automated blood cell separator

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Other Products from FRESENIUS KABI WARRENDALE
Products from the same manufacturer (1 products)