STATSTRIP Xpress GLU KET Control Level 1 - Indonesia BPOM Medical Device Registration
STATSTRIP Xpress GLU KET Control Level 1 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101813113. The device is manufactured by NOVA BIOMEDICAL from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. TAMARA OVERSEAS CORPORINDO.
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
NOVA BIOMEDICALCountry of Origin
United States
Authorized Representative
PT. TAMARA OVERSEAS CORPORINDOAR Address
Jl. Pinangsia Timur No. 49 Jakarta 11110
Registration Date
Sep 20, 2022
Expiry Date
Feb 09, 2027
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
STAT PROFILE pHOx /BASIC CONTROLS AUTO-CARTRIDGE, 110
STAT PROFILE pHOx Plus L Controls Auto-Cartridge, 330
Allegro C-Reactive Protein Test Cartridges
STAT PROFILE pHOx Plus L/C/M Reference Sensor
Stat Profile pHOx Ultra™ / CCX™ BUN Membrane Kit
STAT PROFILE pHOx PLUS/C CONTROL AUTO-CARTRIDGE, 75
STAT PROFILE pHOx Ultra™ / CCX™ pO2 Sensor
Nova Performance Check Solution GLU/BUN/CREAT
STAT PROFILE pHOx /Basic Controls Auto-Cartridge, 75
Stat Profile pHOx Ultra™ / CCX ™ Lactate Sensor
Stat Profile Prime Plus Calibrator Cartridge 700 Sample
NOVA BIOMEDICAL CORPORATION
ALLEGRO Prothrombin Time/International Normalized Ratio Test Cartridges
NOVA BIOMEDICAL CORPORATION
RANDOX RX series EtOH (ETHANOL)
RANDOX LABORATORIES LTD
RANDOX RX series ASO 2 (ANTI-STREPTOLYSIN-O 2)
RANDOX LABORATORIES LTD
STAT PROFILE pHOx ULTRA™/CCX™ Chloride Sensor
NOVA BIOMEDICAL CORPORATION
RANDOX RX series Iron (Fe)
RANDOX LABORATORIES LTD
Stat Profile pHOx Ultra™ / CCX™ Potassium Sensor
NOVA BIOMEDICAL CORPORATION.
STAT PROFILE pHOx Plus/L/C/M Calcium Sensor
NOVA BIOMEDICAL CORPORATION.
Stat Profile pHOx Reference Sensor
NOVA BIOMEDICAL
Stat Profile pHOx Ultra™ / CCX™ BUN Base Sensor
NOVA BIOMEDICAL