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AQUALINE - Indonesia BPOM Medical Device Registration

AQUALINE is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805022197. The device is manufactured by HAEMOTRONIC S.P.A from Italy, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BISAWI GROWS IN HARMONY.

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 : C
AQUALINE
Analysis ID: AKL 20805022197

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

HAEMOTRONIC S.P.A

Country of Origin

Italy

Authorized Representative

PT. BISAWI GROWS IN HARMONY

AR Address

Graha Kencana Blok EU Jl. Raya Perjuangan No.88 Kebun Jeruk Jakarta Barat

Registration Date

Oct 11, 2022

Expiry Date

Dec 31, 2026

Product Type

Therapeutic Gastroenterology-Urology Equipment

Hemodialysis system and accessories.

Non Electromedic Sterile

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