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BIONIL MONOx - Indonesia BPOM Medical Device Registration

BIONIL MONOx is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603026605. The device is manufactured by BIOSINTEX S.R.L. from Romania, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is BIO AXION HEALTHINDO.

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 : C
BIONIL MONOx
Analysis ID: AKL 21603026605

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

BIOSINTEX S.R.L.

Country of Origin

Romania

Authorized Representative

BIO AXION HEALTHINDO

AR Address

Komplek Golden Plaza Blok G39-G42, Jl. RS Fatmawati, Kode Pos 12420 Kel. Gandaria Selatan, Kec. Cilandak, Kota Jakarta Selata, Prov. DKI Jakarta

Registration Date

Oct 19, 2023

Expiry Date

Jun 26, 2028

Product Type

Surgical Equipment

Nonabsorbable polyamide surgical suture.

Non Electromedic Sterile

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