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DORADO PTA Balloon Dilatation Catheters - Indonesia BPOM Medical Device Registration

DORADO PTA Balloon Dilatation Catheters is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501123887. The device is manufactured by BIOMERICS FMI from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ITAMA RANORAYA.

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BPOM Registered
Risk Class Kelas Resiko : C
DORADO PTA Balloon Dilatation Catheters
Analysis ID: AKL 20501123887

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

BIOMERICS FMI

Country of Origin

United States

Authorized Representative

PT. ITAMA RANORAYA

AR Address

MT Haryono Square Lantai 1 Unit 1, Jl. Otto Iskandardinata Raya No. 390 RT 006 RW 012 Kel. Bidara Cina, Kec. Jatinegara, Jakarta Timur, DKI Jakarta

Registration Date

Jul 02, 2021

Expiry Date

Dec 31, 2025

Product Type

Diagnostic Cardiology Equipment

Percutaneous catheter.

Non Electromedic Sterile

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