ANMDMR - Baza Națională de Date a Dispozitivelor Medicale

F1, F2 - Producătorii cu sediul în România care introduc dispozitive medicale pe piață sub propriul nume și reprezentanții autorizați în UE care introduc pe piața din România dispozitive medicale fabricate de producatori cu sediul social care nu se află pe teritoriul UE *

Actualizat în 02.11.2026
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Denumire dispozitiv Tip Cod Clasa Cod înregistrare Producator Reprezentant autorizat Data Observații
γ-GT liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 50ml + 2 x 20ml (Hitachi 911/912) GT2080 IN VITRO ALTELE RO/IVD-139-278-103 27-05-2010
γ-GT liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 100ml + 4 x 20ml (Hitachi 911/912) GT2070 IN VITRO ALTELE RO/IVD-139-278-104 27-05-2010
γ-GT liquid / R1, R2 (5+1) (IFCC / kinetic) 6 x 66ml + 6 x 16ml (Hitachi 917)  GT2090 IN VITRO ALTELE RO/IVD-139-278-105 27-05-2010
Glycerol, Free liquid / R1, R2 (5+1) (GPO / kinetic) 2 x 50ml + 1 x 20ml + Std  GN2030 IN VITRO ALTELE RO/IVD-139-278-106 27-05-2010
Glucose Perchlorat (additional reagent for HK method) 1 x 500ml GL8060 IN VITRO ALTELE RO/IVD-139-278-107 27-05-2010
Glucose liquid / R1, R2 (5+1) (HK / 2 point) 4 x 50ml + 2 x 20ml (Hitachi 911/912) GL2080 IN VITRO ALTELE RO/IVD-139-278-108 27-05-2010
Glucose liquid / R1, R2 (5+1) (HK / 2 point) 4 x 100ml + 2 x 40ml (Hitachi 911/912) GL2070 IN VITRO ALTELE RO/IVD-139-278-109 27-05-2010
Glucose liquid / R1, R2 (5+1) (HK / 2 point) 6 x 66ml + 6 x 17ml (Hitachi 917) GL2090 IN VITRO ALTELE RO/IVD-139-278-110 27-05-2010
Glucose liquid / R1, R2 (100+1) (HK / endpoint) 4 x 100ml + 1 x 5ml + Std GL9020 IN VITRO ALTELE RO/IVD-139-278-111 27-05-2010
Glucose liquid / R1, R2 (100+1) (HK / endpoint) 2 x 500ml + 2 x 5ml + Std GL9060 IN VITRO ALTELE RO/IVD-139-278-112 27-05-2010
Glucose liquid / monoreagent (GOD-PAP / endpoint) 4 x 100ml + Std GL1020 IN VITRO ALTELE RO/IVD-139-278-113 27-05-2010
Glucose liquid / monoreagent (GOD-PAP / endpoint) 2 x 500ml + Std GL1060 IN VITRO ALTELE RO/IVD-139-278-114 27-05-2010
Glucose liquid / monoreagent (GOD-PAP / endpoint) 4 x 50ml (Hitachi 911/912) GL1080 IN VITRO ALTELE RO/IVD-139-278-115 27-05-2010
Glucose liquid / monoreagent (GOD-PAP / endpoint) 4 x 100ml (Hitachi 911/912) GL1070 IN VITRO ALTELE RO/IVD-139-278-116 27-05-2010
Glucose liquid / monoreagent (GOD-PAP / endpoint) 6 x 66ml (Hitachi 917) GL1090 IN VITRO ALTELE RO/IVD-139-278-117 27-05-2010
GOT / ASAT liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 25ml + 2 x 10ml GO2010 IN VITRO ALTELE RO/IVD-139-278-118 27-05-2010
GOT / ASAT liquid / R1, R2 (5+1) (IFCC / kinetic) 2 x 50ml + 1 x 20ml GO2030 IN VITRO ALTELE RO/IVD-139-278-119 27-05-2010
GOT / ASAT liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 100ml + 2 x 40ml GO2040 IN VITRO ALTELE RO/IVD-139-278-120 27-05-2010
GOT / ASAT liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 50ml + 2 x 20ml (Hitachi 911/912) GO2080 IN VITRO ALTELE RO/IVD-139-278-121 27-05-2010
GOT / ASAT liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 100ml + 2 x 20ml (Hitachi 911/912) GO2071 IN VITRO ALTELE RO/IVD-139-278-122 27-05-2010
GOT / ASAT liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 66ml + 4 x 16ml (Hitachi 917)  GO2072 IN VITRO ALTELE RO/IVD-139-278-123 27-05-2010
GPT / ALAT liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 25ml + 2 x 10ml GP2010 IN VITRO ALTELE RO/IVD-139-278-124 27-05-2010
GPT / ALAT liquid / R1, R2 (5+1) (IFCC / kinetic) 2 x 50ml + 1 x 20ml GP2030 IN VITRO ALTELE RO/IVD-139-278-125 27-05-2010
GPT / ALAT liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 100ml + 2 x 40ml GP2040 IN VITRO ALTELE RO/IVD-139-278-126 27-05-2010
GPT / ALAT liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 50ml + 2 x 20ml (Hitachi 911/912) GP2080 IN VITRO ALTELE RO/IVD-139-278-127 27-05-2010
GPT / ALAT liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 100ml + 4 x 20ml (Hitachi 911/912) GP2071 IN VITRO ALTELE RO/IVD-139-278-128 27-05-2010
GPT / ALAT liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 66ml + 4 x 16ml (Hitachi 917) GP2072 IN VITRO ALTELE RO/IVD-139-278-129 27-05-2010
α-HBDH liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 25ml + 1 x 20ml HB2010 IN VITRO ALTELE RO/IVD-139-278-130 27-05-2010
α-HBDH liquid / R1, R2 (5+1) (DGKC / kinetic) 2 x 100ml + 2 x 20ml  HB2020 IN VITRO ALTELE RO/IVD-139-278-131 27-05-2010
α-HBDH liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 50ml + 2 x 20ml (Hitachi 911/912)   HB2080 IN VITRO ALTELE RO/IVD-139-278-132 27-05-2010
α-HBDH liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 22ml + 2 x 10ml (Hitachi 917)  HB2072 IN VITRO ALTELE RO/IVD-139-278-133 27-05-2010
HDL Precipitation liquid /monoreagent (PTA/PWS / additional reagent) 2 x 100ml CH8730 IN VITRO ALTELE RO/IVD-139-278-134 27-05-2010
HDL direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 4 x 25ml + 2 x 17ml CH6710 IN VITRO ALTELE RO/IVD-139-278-135 27-05-2010
HDL direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 3 x 50ml + 1 x 50ml CH6730 IN VITRO ALTELE RO/IVD-139-278-136 27-05-2010
HDL direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 3 x 50ml + 1 x 50ml (Hitachi 911/912) CH6780 IN VITRO ALTELE RO/IVD-139-278-137 27-05-2010
HDL direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 3 x 100ml + 1 x 100ml (Hitachi 911/912) CH6770 IN VITRO ALTELE RO/IVD-139-278-138 27-05-2010
HDL direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 6 x 54ml + 6 x 20ml (Hitachi 917) CH6790 IN VITRO ALTELE RO/IVD-139-278-139 27-05-2010
Hemoglobin liquid / monoreagent (10X) (Hemiglobincyanide / endpoint) 4 x 100ml HG1020 IN VITRO ALTELE RO/IVD-139-278-140 27-05-2010
Lactate liquid / monoreagent (LOD-PAP / endpoint) 2 x 50ml + Std LA1030 IN VITRO ALTELE RO/IVD-139-278-141 27-05-2010
Lactate liquid / monoreagent (LOD-PAP / endpoint) 2 x 50ml (Hitachi 911/912) LA1080 IN VITRO ALTELE RO/IVD-139-278-142 27-05-2010
LDH-L liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 25ml + 2 x 10ml LD2210 IN VITRO ALTELE RO/IVD-139-278-143 27-05-2010
LDH-L liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 50ml + 2 x 20ml (Hitachi 911/912) LD2280 IN VITRO ALTELE RO/IVD-139-278-144 27-05-2010
LDH-L liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 100ml + 4 x 20ml (Hitachi 911/912) LD2270 IN VITRO ALTELE RO/IVD-139-278-145 27-05-2010
LDH-L liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 25ml + 2 x 10ml LD2110 IN VITRO ALTELE RO/IVD-139-278-146 27-05-2010
LDH-L liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 50ml + 2 x 20ml (Hitachi 911/912) LD2180 IN VITRO ALTELE RO/IVD-139-278-147 27-05-2010
LDH-L liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 100ml + 4 x 20ml (Hitachi 911/912) LD2170 IN VITRO ALTELE RO/IVD-139-278-148 27-05-2010
LDH-L liquid / R1, R2 (5+1) (IFCC / kinetic) 6 x 66ml + 6 x 16ml (Hitachi 917) LD2190 IN VITRO ALTELE RO/IVD-139-278-149 27-05-2010
LDH-P liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 25ml + 2 x 10ml LD2310 IN VITRO ALTELE RO/IVD-139-278-150 27-05-2010
LDH-P liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 50ml + 2 x 20ml (Hitachi 911/912) LD2380 IN VITRO ALTELE RO/IVD-139-278-151 27-05-2010
LDH-P liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 100ml + 4 x 20ml (Hitachi 911/912) LD2371 IN VITRO ALTELE RO/IVD-139-278-152 27-05-2010

*Conform art. 31 alin. (2) din HG nr 54/2009, art. 30 din HG nr. 798/2003 şi art. 30 din HG nr. 55/2009