Pure Global

NEXGEN Complete Knee Solution Tibial Block Augment Precoat - Indonesia BPOM Medical Device Registration

NEXGEN Complete Knee Solution Tibial Block Augment Precoat is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302918728. The device is manufactured by ROOM INC from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is KALMED SEJAHTERA INDONESIA.

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
NEXGEN Complete Knee Solution Tibial Block Augment Precoat
Analysis ID: AKL 21302918728

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

ROOM INC

Country of Origin

United States

Authorized Representative

KALMED SEJAHTERA INDONESIA

AR Address

JL.TAMAN MINI PINTU 2 NO. 2, RT. 006 RW. 004

Registration Date

Aug 07, 2024

Expiry Date

Dec 08, 2026

Product Type

Prosthetic Orthopedic Equipment

Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

Non Electromedic Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing