HEMOSIL Protein S Activity - Indonesia BPOM Medical Device Registration
HEMOSIL Protein S Activity is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207812303. The device is manufactured by INSTRUMENTATION LABORATORY COMPANY. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.
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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
INSTRUMENTATION LABORATORY COMPANY.Country of Origin
United States
Authorized Representative
PT. ENSEVAL MEDIKA PRIMAAR Address
JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG
Registration Date
Aug 13, 2024
Expiry Date
Dec 31, 2027
Product Type
Haematology Package and Kit
Factor deficiency test.
Invitro Diagnostics
HEMOSIL Apixaban Calibrators
HEMOSIL Apixaban Controls
HEMOSIL Rivaroxaban Calibrators
HEMOSIL Rivaroxaban Controls
HEMOSIL La Positive Control
HEMOSIL Rinse Solution
HEMOSIL La Negative Control
HEMOSIL Protein C
HEMOSIL Factor IX Deficient Plasma
HEMOSIL Q.F.A. Thrombin (Bovine)
MEDRAD Salient Contrast Injector Wireless
PLEXUS MANUFACTURING SDN. BHD. (HILLSIDE)
MEDRAD Salient Contrast Injector Non-Wireless
PLEXUS MANUFACTURING SDN. BHD. (HILLSIDE)
HOKAPI™ CUVETTE
SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD
DENSICHECK Plus Instrument for VITEK 2 System and Accessories
BIOMERIEUX INC.
VITEK MS System and Accessories
KRATOS ANALYTICAL LTD.
BIOMERIEUX Mycoline
AIDIAN
BIOMERIEUX Uriline
AIDIAN
BacT/ALERT VIRTUO Microbial Detection System and Accessories
BIOMERIEUX INC. (MISSOURI)
Bact/Alert 3D 240
BIOMERIEUX INC. (Missouri)
FILMARRAY Torch and accessories
BIOFIRE DIAGNOSTICS, LLC