TIPSAN T08 Tibial Component with Cemented - Indonesia BPOM Medical Device Registration
TIPSAN T08 Tibial Component with Cemented is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302220198. The device is manufactured by TIPSAN TIBBI ALETLERI SANAYI VE TIC. A.S. from Turkey, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. RONTHKARD SPINETION 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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
TIPSAN TIBBI ALETLERI SANAYI VE TIC. A.S.Country of Origin
Turkey
Authorized Representative
PT. RONTHKARD SPINETION INDONESIAAR Address
Jl. Gubeng Kertajaya X No. 61 B, Kel. Kertajaya. Kec. Gubeng, Surabaya, Jawa Timur
Registration Date
Apr 26, 2022
Expiry Date
Nov 11, 2026
Product Type
Prosthetic Orthopedic Equipment
Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Non Electromedic Sterile
TIPSAN Posterior Cervical System
TIPSAN Simplex Posterior Spinal System
TIPSAN - Expandable Corpectomy Cages
TIPSAN Spinal System Instrument Set
TIPSAN Modular Straight Stem Cemented
TIPSAN Acetabular Cup
TIPSAN T08 Posterior Stabilized Tibial Insert
TIPSAN Modular Head For Total Hip Prosthesis
TIPSAN Modular Bipolar Cup Uncemented
OF Cement
LABORATORIOS SL S.A
RONTHKARD Arthro+ Knee System Instrument Set
JUST MEDICAL DEVICES (TIANJIN) CO., LTD
RONTHKARD ARTHRO+ HIP SYSTEM INSTRUMENT SET
JUST MEDICAL DEVICES (TIANJIN) CO., LTD
RONTHKARD ARTHRO+ TOTAL HIP REPLACEMENT SYSTEM
JUST MEDICAL DEVICES (TIANJIN) CO., LTD.
RONTHKARD - ARTHRO+ Total Knee Replacement System
JUST MEDICAL DEVICES (TIANJIN) CO., LTD.
TIPSAN Prizma Hip Femoral Stem and Revision with HA coated Uncemented
TIPSAN TIBBI ALETLERI SAN. TฤฐC. ANONIM SIRKETI
TIPSAN Posterior Cervical System
TIPSAN TIBBI ALETLERI SANAYI VE TIC. A.S.
TIPSAN Simplex Posterior Spinal System
TIPSAN TIBBI ALETLERI SANAYI VE TIC. A.S.
TIPSAN - INSTRUMENT SET
TIPSAN TIBBI ALETLERI SAN. TฤฐC. ANONIM SIRKETI
TIPSAN Modular Straight Stem Cemented
TIPSAN TIBBI ALETLERI SANAYI VE TIC. A.S.