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RESTORE DEB Paclitaxel Releasing PTCA Ballon Catheter - Indonesia BPOM Medical Device Registration

RESTORE DEB Paclitaxel Releasing PTCA Ballon Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503220081. The device is manufactured by CARDIONOVUM GMBH from Germany, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. STAR OF SUCCESS AWARD.

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BPOM Registered
Risk Class Kelas Resiko : D
RESTORE DEB Paclitaxel Releasing PTCA Ballon Catheter
Analysis ID: AKL 30503220081

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

CARDIONOVUM GMBH

Country of Origin

Germany

Authorized Representative

PT. STAR OF SUCCESS AWARD

AR Address

JL. CILEDUG RAYA RUKO UBUD VILLAGE BLOK KUTA A NO.25, CILEDUG KOTA TANGERANG

Registration Date

Aug 16, 2022

Expiry Date

Dec 31, 2025

Product Type

Prosthetic Cardiology Equipment

Drug eluting balloon

Non Electromedic Sterile

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