SCOREFLEX PTA Balloon Dilatation Catheter - Indonesia BPOM Medical Device Registration

SCOREFLEX PTA Balloon Dilatation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20505719272. The device is manufactured by ORBUSNEICH MEDICAL, B.V. from Netherlands, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MAIN REVASS MEDIKA.

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BPOM Registered

Risk Class Kelas Resiko : C

SCOREFLEX PTA Balloon Dilatation Catheter

Analysis ID: AKL 20505719272

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

ORBUSNEICH MEDICAL, B.V.

Country of Origin

Netherlands

Authorized Representative

PT. MAIN REVASS MEDIKA

AR Address

Jl. Dewi Sartika No. 4B RT 004/007 Kel. Cililitan Kec. Kramat jati

Registration Date

Jul 28, 2022

Expiry Date

Apr 11, 2027

Product Type

Diagnostic Cardiology Equipment

Percutaneous catheter.

Non Electromedic Sterile

DJ Fang

MedTech Regulatory Expert

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