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FATHOM-16 Steerable Guidewire - Indonesia BPOM Medical Device Registration

FATHOM-16 Steerable Guidewire is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501712227. The device is manufactured by BOSTON SCIENTIFIC CORPORATION from Costa Rica, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is BOSTON SCIENTIFIC INDONESIA.

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
FATHOM-16 Steerable Guidewire
Analysis ID: AKL 20501712227

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Costa Rica

Authorized Representative

BOSTON SCIENTIFIC INDONESIA

AR Address

PRUDENTIAL TOWER, LT. 28, JL. JEND. SUDIRMAN KAV. 79

Registration Date

Apr 17, 2024

Expiry Date

Apr 07, 2028

Product Type

Diagnostic Cardiology Equipment

Catheter guide wire.

Non Electromedic Sterile

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