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R3 Acetabular System - Indonesia BPOM Medical Device Registration

R3 Acetabular System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302815017. The device is manufactured by SMITH & NEPHEW, INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. TAWADA HEALTHCARE.

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
R3 Acetabular System
Analysis ID: AKL 21302815017

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. TAWADA HEALTHCARE

AR Address

Rukan Permata Senayan Blok A18-19 Lantai 5 Jl. Tentara Pelajar No. 5

Registration Date

Oct 14, 2024

Expiry Date

Dec 31, 2027

Product Type

Prosthetic Orthopedic Equipment

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

Non Electromedic Sterile

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