Pure Global

UNITED Hip System GTF II Stem - Indonesia BPOM Medical Device Registration

UNITED Hip System GTF II Stem is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302711650. The device is manufactured by UNITED ORTHOPEDIC CORPORATION from Taiwan (China), and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BIOTECH INTI KORPORINDO.

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
UNITED Hip System GTF II Stem
Analysis ID: AKL 21302711650

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Taiwan (China)

Authorized Representative

PT. BIOTECH INTI KORPORINDO

AR Address

Komplek Duta Merlin Blok D No. 11-13 Jalan Gajah Mada no 3-5 Lt. 2

Registration Date

May 20, 2023

Expiry Date

Aug 23, 2027

Product Type

Prosthetic Orthopedic Equipment

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

Non Electromedic Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing