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EMBOSPHERE Microspheres - Indonesia BPOM Medical Device Registration

EMBOSPHERE Microspheres is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30805122191. The device is manufactured by BIOSPHERE MEDICAL SA from France, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. REKAMILENIUMINDO SELARAS.

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
EMBOSPHERE Microspheres
Analysis ID: AKL 30805122191

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

France

Authorized Representative

PT. REKAMILENIUMINDO SELARAS

AR Address

Jl. Tomang Raya No. 51B RT 01 RW 05, Kelurahan Tomang

Registration Date

Nov 18, 2023

Expiry Date

Dec 31, 2025

Product Type

Therapeutic Gastroenterology-Urology Equipment

Prostatic artery embolization device

Non Electromedic Sterile

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