MINDRAY Ventilator - Indonesia BPOM Medical Device Registration

MINDRAY Ventilator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20403321863. The device is manufactured by SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is MINDRAY MEDICAL INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : C

MINDRAY Ventilator

Analysis ID: AKL 20403321863

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Country of Origin

China

Authorized Representative

MINDRAY MEDICAL INDONESIA

AR Address

Menara DEA II Lt.17, Jl. Mega Kuningan Barat Kav.E4.3 No.1-2, Kel. Kuningan Timur, Kec.Setiabudi Kawasan Mega Kuningan, Jakarta Selatan

Registration Date

Dec 19, 2023

Expiry Date

Jan 28, 2027

Product Type

Therapeutic Anesthesia Equipment

Continuous ventilator.

Non Radiation Electromedics

DJ Fang

MedTech Regulatory Expert

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Kelas Resiko : C

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MINDRAY Ventilator - Indonesia BPOM Medical Device Registration

Risk Classification

Product Class

Manufacturer

Country of Origin

Authorized Representative

AR Address

Registration Date

Expiry Date

Product Type

DJ Fang

MINDRAY Ventilator

MINDRAY Ventilator

MINDRAY Ventilator

MINDRAY Ventilator

MINDRAY Ventilator

MINDRAY Ventilator

MINDRAY Ventilator

MINDRAY Ventilator

MINDRAY Ventilator

MINDRAY Ventilator

MINDRAY ME7 Diagnostic Ultrasound System

MINDRAY ASO/CRP/RF Triple Control

MINDRAY ALD Calibrators

MINDRAY Hypertension Multi Control (H)

MINDRAY M-5LEO (I) Bright

MINDRAY LC LYSE

MINDRAY Urine Sediment Control Level III

MINDRAY Hypertension Multi Control (L)

MINDRAY ACTH Control (L)

MINDRAY ALD II Aldosterone (CLIA)

MINDRAY C-reactive Protein (CRP) Kit (Latex Immunoturbidimetric Method)

MINDRAY Diagnostic Ultrasound System

MINDRAY Anesthesia System

MINDRAY MYO Calibrators

MINDRAY Digital Radiography System

MINDRAY Digital Radiography System

MINDRAY sCD14-ST Control (L)

MINDRAY TESTO II Testosterone (CLIA)

MINDRAY HbA1c Hemoglobin A1c Kit (Enzymatic Assay Method) – Twin Test

MINDRAY ToRCH IgM Positive Control