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PULSECATH iVAC 2L - Indonesia BPOM Medical Device Registration

PULSECATH iVAC 2L is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503220036. The device is manufactured by PULSECATH B.V. from Netherlands, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. QUALTEK CONSULTANT JAKARTA.

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 : D
PULSECATH iVAC 2L
Analysis ID: AKL 30503220036

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

PULSECATH B.V.

Country of Origin

Netherlands

Authorized Representative

PT. QUALTEK CONSULTANT JAKARTA

AR Address

Icon Business Park Blok K No 6, BSD City, Kab Tangerang, Banten

Registration Date

Apr 08, 2023

Expiry Date

Feb 08, 2027

Product Type

Prosthetic Cardiology Equipment

Intra-aortic balloon and control system

Non Electromedic Sterile

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