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S.M.A.R.T CONTROL ™ Nitinol Stent System - Indonesia BPOM Medical Device Registration

S.M.A.R.T CONTROL ™ Nitinol Stent System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31003320195. The device is manufactured by CARDINAL HEALTH MEXICO 244 S DE RL DE CV from Mexico, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. WEGO MEDIKA 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
S.M.A.R.T CONTROL ™ Nitinol Stent System
Analysis ID: AKL 31003320195

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Mexico

Authorized Representative

PT. WEGO MEDIKA INDONESIA

AR Address

Jl. Tanah Abang II No.67 Kel. Petojo Selatan, Kec. Gambir, Jakarta Pusat

Registration Date

Apr 22, 2024

Expiry Date

Apr 19, 2028

Product Type

Therapeutic Neurology Equipment

Peripheral Stent

Non Electromedic Sterile

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