EMIT® II Plus 6-AM/Ecstasy Calibrator/Control Level 1 - Indonesia BPOM Medical Device Registration
EMIT® II Plus 6-AM/Ecstasy Calibrator/Control Level 1 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20103320665. The device is manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC., USA from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. SIEMENS HEALTHINEERS 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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
SIEMENS HEALTHCARE DIAGNOSTICS INC., USACountry of Origin
United States
Authorized Representative
PT. SIEMENS HEALTHINEERS INDONESIAAR Address
Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl.Tahi Bonar Simatupang Kav. 88
Registration Date
Dec 22, 2023
Expiry Date
Jan 28, 2025
Product Type
Clinical Toxicology Test System
Multi parameter clinical toxicology test system
Invitro Diagnostics
EMIT Calibrator / Control Level 3
Emit Calibrator / Control Level 4
Emit 2000 Valproic Acid Calibrators
Emit II Plus Benzodiazepine Assay
Emit Ethyl Alcohol Negative Calibrator
EMIT Calibrator/Control Level 5
Emit II Plus 6-AM/Ecstasy Calibrator/Control Level 2
Syva Emit Calibrator / Control Level 1
Syva Emit Calibrator / Control Level 0 (negative)
SYVA Emit II Plus Opiate Assay
ADVIA Centaur Calibrator D
SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)
DIMENSION Revised C-Reactive Protein Calibrator (RCRP CAL)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
IMMULITE 2000 Systems Allergen Specific IgE Universal Kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
IMMULITE 2000 3gAllergy Specific IgE Positive Control for D1 &D2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
ADVIA Centaur Anti-HBs2 Quality Control (aHBs2 QC)
SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)
DIMENSION Bilirubin Calibrator (TBI/DBI CAL)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
ADVIA Centaur CA 15-3
SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)
ADVIA Centaur Insulin (IRI)
MINARIS MEDICAL CO., LTD.
CLINITEK Status+ Analyzer and Accessories
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
DIMENSION Tacrolimus Calibrator
SIEMENS HEALTHCARE DIAGNOSTICS INC.