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BIOSTER Polyester Non-Absorbable Suture - Indonesia BPOM Medical Device Registration

BIOSTER Polyester Non-Absorbable Suture is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603816043. 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 PT. 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
BIOSTER Polyester Non-Absorbable Suture
Analysis ID: AKL 21603816043

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

BIOSINTEX S.R.L.

Country of Origin

Romania

Authorized Representative

PT. BIO AXION HEALTHINDO

AR Address

Komplek golden plaza Blok E-43, Jl. RS.Fatmawati no.15. Jakarta Selatan

Registration Date

Aug 30, 2018

Expiry Date

Dec 15, 2023

Product Type

Surgical Equipment

Nonabsorbable poly(ethylene terephthalate) surgical suture.

Non Electromedic Sterile

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