Pure Global

SIGMA Knee System (Johnson & Johnson Medical Suzhou) - Indonesia BPOM Medical Device Registration

SIGMA Knee System (Johnson & Johnson Medical Suzhou) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302321032. The device is manufactured by JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is JOHNSON AND JOHNSON INDONESIA TWO.

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
SIGMA Knee System (Johnson & Johnson Medical Suzhou)
Analysis ID: AKL 21302321032

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

JOHNSON AND JOHNSON INDONESIA TWO

AR Address

K-Link Tower, Lt. 15, Jl. Jend. Gatot Subroto kav. 59A, Kuningan, Setiabudi, Jakarta Selatan, Desa/Kelurahan Kuningan Timur, Kec. Setiabudi, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta, Kode Pos: 12950

Registration Date

Dec 13, 2023

Expiry Date

Feb 21, 2028

Product Type

Prosthetic Orthopedic Equipment

Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

Non Electromedic Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing