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XPANSE Balloon Dilation Catheter - Indonesia BPOM Medical Device Registration

XPANSE Balloon Dilation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30505220007. The device is manufactured by NATEC MEDICAL LTD from Mauritius, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. TRITRA PRIMA INDONESIA.

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Risk Class Kelas Resiko : D
XPANSE Balloon Dilation Catheter

XPANSE Balloon Dilatation Catheter

Analysis ID: AKL 30505220007

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

NATEC MEDICAL LTD

Country of Origin

Mauritius

Authorized Representative

PT. TRITRA PRIMA INDONESIA

AR Address

Taman Sari Persada Blok F-1 Nomor 10

Registration Date

Jan 29, 2022

Expiry Date

Aug 24, 2026

Product Type

Therapeutic Cardiology Equipment

(Tidak digunakan) Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (double)

Non Electromedic Sterile

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