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DIGISTAT Care - Indonesia BPOM Medical Device Registration

DIGISTAT Care is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20502023187. The device is manufactured by ASCOM UMS SRL UNIPERSONALE from Italy, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. IDS MEDICAL SYSTEMS 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
DIGISTAT Care
Analysis ID: AKL 20502023187

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Italy

Authorized Representative

PT. IDS MEDICAL SYSTEMS INDONESIA

AR Address

Gedung Wisma 76, Lantai 17 & 22, Jl. LetJend. S. Parman Kav.76, Kelurahan Slipi, Kecamatan Palmerah, 11410

Registration Date

May 29, 2023

Expiry Date

Jan 09, 2028

Product Type

Monitoring Cardiology Equipment

Cardiac monitor (including cardiotachometer and rate alarm).

Non Radiation Electromedics

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