BIOPTIMAL Biotray Procedure Pack - Indonesia BPOM Medical Device Registration

BIOPTIMAL Biotray Procedure Pack is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501220423. The device is manufactured by BIOXIN MEDICAL CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. IDS MEDICAL SYSTEMS INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : B

BIOPTIMAL Biotray Procedure Pack

Analysis ID: AKL 20501220423

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BIOXIN MEDICAL CO., LTD

Country of Origin

China

Authorized Representative

PT. IDS MEDICAL SYSTEMS INDONESIA

AR Address

Gedung Wisma 76, Lantai 17 & 22, Jl. LetJend. S. Parman Kav.76, Kelurahan Slipi, Kecamatan Palmerah, 11410

Registration Date

Nov 30, 2023

Expiry Date

Sep 12, 2025

Product Type

Diagnostic Cardiology Equipment

Catheter introducer.

Non Electromedic Sterile

DJ Fang

MedTech Regulatory Expert

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