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EnSite X EP System Surface Electrode Kit - Indonesia BPOM Medical Device Registration

EnSite X EP System Surface Electrode Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20502320675. The device is manufactured by ABBOTT MEDICAL COSTA RICA LTDA from Costa Rica, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. NUGRA KARSERA.

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
EnSite X EP System Surface Electrode Kit
Analysis ID: AKL 20502320675

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Costa Rica

Authorized Representative

PT. NUGRA KARSERA

AR Address

Rukan Graha Mas Pemuda, Jalan Pemuda Blok AA/ 10

Registration Date

Jun 16, 2023

Expiry Date

Nov 08, 2027

Product Type

Monitoring Cardiology Equipment

Electrocardiograph electrode.

Non Electromedic Non Sterile

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