HDL DIRECT LS - Indonesia BPOM Medical Device Registration
HDL DIRECT LS is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101027713. The device is manufactured by MTD DIAGNOSTICS SRL. from Italy, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BAVARIA COMBININDO.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
MTD DIAGNOSTICS SRL.Country of Origin
Italy
Authorized Representative
PT. BAVARIA COMBININDOAR Address
Jl. Ciledug Raya No. 232 Lt. 1 & 2 RT. 008 RW. 001
Registration Date
Oct 16, 2024
Expiry Date
Sep 20, 2027
Product Type
Clinical Chemistry Test System
Lipoprotein test system (kit & cair)
Invitro Diagnostics
MTD Creatine Kinase MB LS 4+1
MTD Chemistry Control N
MTD gGT Sz74 LS 4+1
MTD DIAGNOSTICS BILIRUBIN T LS 2nd GEN 4+1
CHEMISTRY MULTICALIBRATOR
MTD TRIGLYCERIDES GPO-PAP LS Mono
MTD LDL-DIRECT LS
MTD GOT ASAT IFCC LS 4+1
GPT ALAT IFCC LS 4+1
MTD Uric Acid Uricase PAP LS Mono
MTD Creatine Kinase MB LS 4+1
MTD DIAGNOSTICS SRL.
MTD Chemistry Control N
MTD DIAGNOSTICS SRL.
MTD gGT Sz74 LS 4+1
MTD DIAGNOSTICS SRL.
MTD DIAGNOSTICS BILIRUBIN T LS 2nd GEN 4+1
MTD DIAGNOSTICS SRL.
CHEMISTRY MULTICALIBRATOR
MTD DIAGNOSTICS SRL.
MTD TRIGLYCERIDES GPO-PAP LS Mono
MTD DIAGNOSTICS SRL.
MTD GOT ASAT IFCC LS 4+1
MTD DIAGNOSTICS SRL.
MTD Uric Acid Uricase PAP LS Mono
MTD DIAGNOSTICS SRL.
MTD GLUCOSE GOD-PAP LS Mono
MTD DIAGNOSTICS SRL.
MTD CREATININE KINETIC LS 4+1
MTD DIAGNOSTICS SRL.

