Pure Global

ACU-SINCH Repair System - Indonesia BPOM Medical Device Registration

ACU-SINCH Repair System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603323193. The device is manufactured by ACUMED LLC from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. PRO-HEALTH INTERNATIONAL.

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
ACU-SINCH Repair System
Analysis ID: AKL 21603323193

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

ACUMED LLC

Country of Origin

United States

Authorized Representative

PT. PRO-HEALTH INTERNATIONAL

AR Address

Komplek Perkantoran Duta Merlin Blok C 35-36 Jalan Gajah Mada 3-5

Registration Date

Feb 02, 2023

Expiry Date

Jan 12, 2027

Product Type

Surgical Equipment

Nonabsorbable poly(ethylene terephthalate) surgical suture.

Non Electromedic Non Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing