DrAccu D-Dimer FIA - Indonesia BPOM Medical Device Registration
DrAccu D-Dimer FIA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207320420. The device is manufactured by ASSURE TECH. (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. PROSPEROUS BIOCARE.
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
ASSURE TECH. (HANGZHOU) CO., LTD.Country of Origin
China
Authorized Representative
PT. PROSPEROUS BIOCAREAR Address
RUKO KRANGGAN PERMAI BLOK RT 017/30
Registration Date
Oct 12, 2023
Expiry Date
May 24, 2026
Product Type
Haematology Package and Kit
Fibrinogen/fibrin degradation products assay.
Invitro Diagnostics
Acuteck Hemoglobin Meter
AyoTes Dengue IgG/IgM Rapid Test Kit (Whole Blood/Plasma/Serum)
DrAccu Testosterone FIA
DrAccu LH FIA
DrAccu Anti-Mullerian Hormone FIA
AyoTes HbsAg Rapid Test (Whole Blood/Serum/Plasma)
AyoTes Gonorrhea Rapid Test (Swab)
AyoTes Chlamydia Rapid Test (Secretion)
AyoTes Tetrahydrocannabinol (THC) Rapid Test (Urine)
AyoTes Methamphetamine (MET) Rapid Test (Urine)
DrAccu PCT FIA
ASSURE TECH (HANGZHOU) CO., LTD.
DrAccu ฮฒ-HCG FIA
ASSURE TECH (HANGZHOU) CO. LTD.
DrAccu Micro-Albumin FIA
ASSURE TECH (HANGZHOU) CO., LTD.
DrAccu AFP FIA
ASSURE TECH (HANGZHOU) CO., LTD.
REALBEST DNA HPV HR Screen (Set 1)
TO VECTOR-BEST
DrAccu Prolactin FIA (Whole Blood/Pasma/Serum)
ASSURE TECH (HANGZHOU) CO., LTD.
RealBest HBV/HCV/HIV PCR
TO VECTOR-BEST
DrAccu Free Triiodothyronine (FT3) FIA
ASSURE TECH (HANGZHOU) CO., LTD.
DrAccu Progestin FIA
ASSURE TECH (HANGZHOU) CO., LTD.
DrAccu E2 FIA
ASSURE TECH (HANGZHOU) CO. LTD.

