AGAPPE SGPT - Indonesia BPOM Medical Device Registration
AGAPPE SGPT is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101220853. The device is manufactured by AGAPPE DIAGNOSTICS SWITZERLAND GMBH. from Switzerland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MULTIMEDILAB KARYAMANDIRI.
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
AGAPPE DIAGNOSTICS SWITZERLAND GMBH.Country of Origin
Switzerland
Authorized Representative
PT. MULTIMEDILAB KARYAMANDIRIAR Address
GP plaza lantai 3 unit 6, jalan Gelora II No. 01
Registration Date
Jun 21, 2022
Expiry Date
Apr 25, 2027
Product Type
Clinical Chemistry Test System
Alanine amino transferase (ALT/SGPT) test system (kit & cair)
Invitro Diagnostics
AGAPPE Albumin Mispa CCXL, CXLpro, CX4
AGAPPE ALKALINE WASHING SOLUTION
AGAPPE Bath Additive
AGAPPE Mispa Count-X Auto Hematology Analyzer and Accessories
AGAPPE Bilirubin Total-TAB
AGAPPE Uric Acid
AGAPPE ASO mispa i3
AGAPPE Bilirubin Direct
AGAPPE Glucose
AGAPPE Total Protein
AGAPPE Mispa-i3 C3
AGAPPE DIAGNOSTICS LTD.
AGAPPE Mispa-i3 C4
AGAPPE DIAGNOSTICS LTD.
DIAGNOSYF 431 CA Automatic Chemistry Analyzer
URIT MEDICAL ELECTRONIC CO., LTD
DIAGNOSYF 200 CA Automatic Chemistry Analyzer
URIT MEDICAL ELECTRONIC CO., LTD
DIAGNOSYF SF 590 5-Diff Hematology Analyzer
URIT MEDICAL ELECTRONIC CO., LTD
DIAGNOSYF SF 70 3-Diff Hematology Analyzer
URIT MEDICAL ELECTRONIC CO., LTD
MAGLUMI Wash Concentrate
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI®IGF-I (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. ( SNIBE )
Anti-HCV MAGLUMI ® (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI ® Aldosterone (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. ( SNIBE )