Passeo-14 Peripheral Dilatation Catheter - Indonesia BPOM Medical Device Registration
Passeo-14 Peripheral Dilatation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501420481. The device is manufactured by BIOTRONIK AG from Switzerland, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is 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 : 2
Manufacturer
BIOTRONIK AGCountry of Origin
Switzerland
Authorized Representative
DCH AURIGA INDONESIAAR Address
DCH AURIGA INDONESIA
Registration Date
Sep 12, 2024
Expiry Date
Mar 27, 2029
Product Type
Diagnostic Cardiology Equipment
Percutaneous catheter.
Non Electromedic Sterile
ORSIRO Mission Sirolimus Eluting Coronary Stent System
SYNSIRO Pro
PANTERA LUX Paclitaxel-Releasing PTCA Balloon Catheter
PANTERA Pro Coronary Dilatation Catheter
PASS 18
PANTERA Leo Fast-Exchange PTCA Catheter
PANTERA Pro Coronary Dilatation Catheter
PK PAPYRUS Covered Coronary Stent System
DYNETIC-35 Peripheral Balloon-Expandable Stent
Pulsar-18 T3 Peripheral Self-expanding Nitinol Stent System
ENTICOS 4 SR
BIOTRONIC SE & CO. KG
ENTICOS 4 S
BIOTRONIC SE & CO. KG
RENAMIC
BIOTRONIK SE & CO., KG
PASS 18
BIOTRONIK AG
ENTICOS 4 D
BIOTRONIK SE & CO., KG
ALTERNA Urostomy Bag [Alterna Upgrade 1pc uro]
COLOPLAST HUNGARY LTD
SENSURA Ostomy Bag [SenSura 1pc closed]
COLOPLAST VOLUME MFG. COSTA RICA SA.
ALTERNA Ostomy Bag [Alterna Upgrade 1pc open]
COLOPLAST HUNGARY LTD
Neutrovis 4-Ply Premium Medical Face Mask
ZHEJIANG CHANGDI MEDICAL CO., LTD
Neutrovis 4-Ply Premium Medical Face Mask
ZHEJIANG CHANGDI MEDICAL CO., LTD

