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AGENT MONORAIL Paclitaxel-Coated PTCA Balloon Catheter - Indonesia BPOM Medical Device Registration

AGENT MONORAIL Paclitaxel-Coated PTCA Balloon Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503612809. The device is manufactured by HEMOTEQ AT from Germany, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. BOSTON SCIENTIFIC INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : D
AGENT MONORAIL Paclitaxel-Coated PTCA Balloon Catheter
Analysis ID: AKL 30503612809

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

HEMOTEQ AT

Country of Origin

Germany

Authorized Representative

PT. BOSTON SCIENTIFIC INDONESIA

AR Address

PRUDENTIAL TOWER, LT. 28, JL. JEND. SUDIRMAN KAV. 79

Registration Date

Dec 03, 2024

Expiry Date

Jan 20, 2027

Product Type

Prosthetic Cardiology Equipment

Drug eluting balloon

Non Electromedic Sterile

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