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PLEXA ProMRI ICD Lead - Indonesia BPOM Medical Device Registration

PLEXA ProMRI ICD Lead is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503420127. The device is manufactured by BIOTRONIC SE & CO. KG from Germany, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. DCH AURIGA 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 : D
PLEXA ProMRI ICD Lead
Analysis ID: AKL 30503420127

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Germany

Authorized Representative

PT. DCH AURIGA INDONESIA

AR Address

DCH AURIGA INDONESIA

Registration Date

Sep 04, 2024

Expiry Date

Aug 21, 2028

Product Type

Prosthetic Cardiology Equipment

Pacemaker lead adaptor.

Non Electromedic Sterile

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