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PASSEO-35 XEO Peripheral Dilatation Catheter - Indonesia BPOM Medical Device Registration

PASSEO-35 XEO Peripheral Dilatation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20505126353. The device is manufactured by BIOTRONIK AG from Switzerland, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MULTIDAYA MEDIKA.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : C
PASSEO-35 XEO Peripheral Dilatation Catheter
Analysis ID: AKL 20505126353

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

BIOTRONIK AG

Country of Origin

Switzerland

Authorized Representative

PT. MULTIDAYA MEDIKA

AR Address

RUKAN NIAGA GUNUNG SAHARI BLOK B-1

Registration Date

Oct 26, 2021

Expiry Date

Jun 01, 2026

Product Type

Therapeutic Cardiology Equipment

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Non Electromedic Sterile

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