Pure Global

ACUMED Fibula Nail 2 System Implant - Indonesia BPOM Medical Device Registration

ACUMED Fibula Nail 2 System Implant is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302320791. 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 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
ACUMED Fibula Nail 2 System Implant
Analysis ID: AKL 21302320791

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

ACUMED LLC

Country of Origin

United States

Authorized Representative

PRO-HEALTH INTERNATIONAL

AR Address

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

Registration Date

Jul 25, 2023

Expiry Date

Jan 12, 2027

Product Type

Prosthetic Orthopedic Equipment

Smooth or threaded metallic bone fixation fastener.

Non Electromedic Non Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing