PLEXA ProMRI ICD Lead - Indonesia BPOM Medical Device Registration
PLEXA ProMRI ICD Lead is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503420127. The device is manufactured by BIOTRONIC SE & CO. KG from Germany, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. DCH AURIGA 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 : 3
Manufacturer
BIOTRONIC SE & CO. KGCountry of Origin
Germany
Authorized Representative
PT. DCH AURIGA INDONESIAAR Address
DCH AURIGA INDONESIA
Registration Date
Sep 04, 2024
Expiry Date
Aug 21, 2028
Product Type
Prosthetic Cardiology Equipment
Pacemaker lead adaptor.
Non Electromedic Sterile
ENTICOS 4 SR
ENTICOS 4 S
RIVACOR 7 HF-T QP
BIOMONITOR III
RIVACOR 7 VR-T
RIVACOR 5 HF-T QP
RIVACOR 5 HF-T
RIVACOR 5 VR-T DX
RIVACOR 3 HF-T QP
RIVACOR 7 VR-T DX
FORTRESS Introducer Sheath System
CONTRACT MEDICAL INTERNATIONAL, GMBH
SENSURA Ostomy Bag [1-piece open]
COLOPLAST VOLUME MANUFACTURING COSTA RICA SA
ORSIRO Mission Sirolimus Eluting Coronary Stent System
BIOTRONIK AG
SYNSIRO Pro
BIOTRONIK AG
PANTERA LUX Paclitaxel-Releasing PTCA Balloon Catheter
BIOTRONIK AG
PASSEO-35 HP Peripheral Dilatation Catheter
CREAGH MEDICAL LTD
PANTERA Pro Coronary Dilatation Catheter
BIOTRONIK AG
SOLIA Implantable Lead
BIOTRONIK SE & CO., KG
ALTERNA Urostomy Bag [Upgrade 2pc uro]
COLOPLAST HUNGARY LTD
SENSURA Click Ostomy Bag [SenSura 2 pc open]
COLOPLAST VOLUME MANUFACTURING COSTA RICA SA

