PASS 18 - Indonesia BPOM Medical Device Registration
PASS 18 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501420367. 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.
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PASSEO 18
Risk Classification
Product Class
Kelas : 2
Manufacturer
BIOTRONIK AGCountry of Origin
Switzerland
Authorized Representative
DCH AURIGA INDONESIAAR Address
DCH AURIGA INDONESIA
Registration Date
Jul 11, 2024
Expiry Date
Mar 18, 2028
Product Type
Diagnostic Cardiology Equipment
Percutaneous catheter.
Non Electromedic Sterile
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