PROLINE – a CRP U-hs - Indonesia BPOM Medical Device Registration
PROLINE – a CRP U-hs is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305220095. The device is manufactured by DIASYS DIAGNOSTIC SYSTEMS GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. PRODIA DIAGNOSTIC LINE.
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
DIASYS DIAGNOSTIC SYSTEMS GMBHCountry of Origin
Germany
Authorized Representative
PT. PRODIA DIAGNOSTIC LINEAR Address
Kawasan Industri Jababeka III Jl. Tekno 1 Blok C 2 D - E - F, Kel. Pasirgombong, Kec. Cikarang Utara, Kab. Bekasi, Jawa Barat Telp. 021-89872722
Registration Date
Mar 31, 2022
Expiry Date
Mar 31, 2025
Product Type
Immunological Test System
C-reactive protein immunological test system.
Invitro Diagnostics
Proline TruLab L Level 2
PROLINE TruLab L Level 1
PROLINE TruCal U
PROLINE TruLab N
Yumizen C Urine Level 1 Control
PROLINE Uric Acid FS TOOS
DSI Urea FS
TruLab Urine Level 1
TruLab Urine Level 2
TRULAB Bicarbonate
PROLINE - a Albumin in Urine/CSF FS (Microalbumin)
DIASYS DIAGNOSTIC SYSTEMS GMBH
PROLINE – b Iron FS Ferene
DIASYS DIAGNOSTIC SYSTEMS GMBH.
PROLINE – b Phosphate FS
DIASYS DIAGNOSTIC SYSTEMS GMBH.
PROLINE – b HDL-c direct FS
DIASYS DIAGNOSTIC SYSTEMS GMBH
PROLINE – b LDL-c direct FS
DIASYS DIAGNOSTIC SYSTEMS GMBH
PROLINE - b TruLab Cystatin C level 2
DIASYS DIAGNOSTIC SYSTEMS GMBH
PROLINE - b TruLab Cystatin C level 1
DIASYS DIAGNOSTIC SYSTEMS GMBH
PROLINE – b TruLab CRP Level 2
DIASYS DIAGNOSTIC SYSTEMS GMBH
PROLINE – b TruCal CRP U
DIASYS DIAGNOSTIC SYSTEMS GMBH
PROLINE – b TruLab CRP hs Level 2
DIASYS DIAGNOSTIC SYSTEMS GMBH

