BIOPTIMAL Accutrans Disposable Pressure Monitoring Kit - Indonesia BPOM Medical Device Registration

BIOPTIMAL Accutrans Disposable Pressure Monitoring Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20502220322. 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 IDS MEDICAL SYSTEMS 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.

Free Database

Powered by Pure Global AI

BPOM Registered

Risk Class Kelas Resiko : B

BIOPTIMAL Accutrans Disposable Pressure Monitoring Kit

Analysis ID: AKL 20502220322

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BIOXIN MEDICAL CO., LTD

Country of Origin

China

Authorized Representative

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

Dec 07, 2023

Expiry Date

Sep 12, 2025

Product Type

Monitoring Cardiology Equipment

Extravascular blood pressure transducer.

Non Electromedic Sterile

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Other Products from BIOXIN MEDICAL CO., LTD

Products from the same manufacturer (5 products)

BIOPTIMAL Biotrans Pressure Monitoring Kit

Kelas Resiko : B

BIOPTIMAL Introducer Kit

Kelas Resiko : B

BIOPTIMAL Biotray Procedure Pack

Kelas Resiko : B

Bioptimal Bipolar Pacing Catheter

Kelas Resiko : B

BIOPTIMAL Central Venous Catheter & Central Venous Catheter Kit (Triple Lumen)

Kelas Resiko : C

Other Products from IDS MEDICAL SYSTEMS INDONESIA

Products with the same authorized representative (10 products)

PORTEX THERMOVENT T, Heat and Moisture Exchanger

SMITHS MEDICAL CZECH REPUBLIC A.S.

Kelas Resiko : B

Portex BLUperc Percutaneous Dilation Tracheostomy Kit

SMITHS MEDICAL CZECH REPUBLIC A.S

Kelas Resiko : B

PORTEX Orator ™ Tracheostomy Speaking Valve

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Kelas Resiko : B

PORTEX Tracheal Intubation Stylet

SMITHS HEALTHCARE MANUFACTURING SA DE C.V.

Kelas Resiko : B

CANON Digital Radiography CXDI-702C Wireless

CANON COMPONENTS, INC

Kelas Resiko : B

LAERDAL The Bag II

POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO., LTD

Kelas Resiko : B

LAERDAL Compact Suction Unit 4 (LCSU4)

DONG GUAN EASTEK PLASTICS & ELECTRONICS CO., LIMITED

Kelas Resiko : B

LAERDAL Thomas Tube Holder

LAERDAL MEDICAL (SUZHOU) CO. LTD.

Kelas Resiko : A

LAERDAL Pocket Mask

LAERDAL MEDICAL (SUZHOU) CO. LTD.

Kelas Resiko : B

LAERDAL SpeedBlocks Head Immobilizer

FORMED PLASTICS, INC.

Kelas Resiko : A