Pure Global

HI-FI® Suture - Indonesia BPOM Medical Device Registration

HI-FI® Suture is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603126201. The device is manufactured by TELEFLEX MEDICAL DE MEXICO, S. DE R.L. DE C.V. from Mexico, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. PETAN DAYA MEDICA.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : C
HI-FI® Suture
Analysis ID: AKL 21603126201

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Mexico

Authorized Representative

PT. PETAN DAYA MEDICA

AR Address

Komplek Setia Budi Point Jl. Setia Budi Blok C No. 3-4 Medan

Registration Date

Aug 01, 2022

Expiry Date

Dec 31, 2026

Product Type

Surgical Equipment

Nonabsorbable poly(ethylene terephthalate) surgical suture.

Non Electromedic Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing