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
LDH-P liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 66ml + 4 x 16ml (Hitachi 917) LD2372 IN VITRO ALTELE RO/IVD-139-278-153 27-05-2010
LDL Precipitation liquid / monoreagent (Heparine / additional reagent) 2 x 100ml  CH8630 IN VITRO ALTELE RO/IVD-139-278-154 27-05-2010
LDL Direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 4 x 25ml + 2 x 17ml CH6610 IN VITRO ALTELE RO/IVD-139-278-155 27-05-2010
LDL Direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 3 x 50ml + 1 x 50ml CH6630 IN VITRO ALTELE RO/IVD-139-278-156 27-05-2010
LDL Direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 3 x 50ml + 1 x 50ml (Hitachi 911/912) CH6680 IN VITRO ALTELE RO/IVD-139-278-157 27-05-2010
LDL Direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 3 x 100ml + 1 x 100ml (Hitachi 911/912) CH6670 IN VITRO ALTELE RO/IVD-139-278-158 27-05-2010
LDL Direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 6 x 54ml + 6 x 20ml (Hitachi 917) CH6690 IN VITRO ALTELE RO/IVD-139-278-159 27-05-2010
Lipase F liquid / R1, R2 (4+1) (Colortest / 2 point) 4 x 25ml + 1 x 25ml  LP2010 IN VITRO ALTELE RO/IVD-139-278-160 27-05-2010
Lipase F liquid / R1, R2 (4+1) (Colortest / 2 point) 4 x 80ml + 4 x 20ml (Hitachi 911/912)  LP2070 IN VITRO ALTELE RO/IVD-139-278-161 27-05-2010
Magnesium liquid / monoreagent (Xylidyl Blue/ endpoint) 2 x 50ml +std. MG1030 IN VITRO ALTELE RO/IVD-139-278-162 27-05-2010
Magnesium liquid / monoreagent (Xylidyl Blue/ endpoint) 4 x 100ml + Std MG1020 IN VITRO ALTELE RO/IVD-139-278-163 27-05-2010
Magnesium liquid / monoreagent (Xylidyl Blue/ endpoint) 4 x 100ml (Hitachi 911/912) MG1070 IN VITRO ALTELE RO/IVD-139-278-164 27-05-2010
Magnesium liquid / R1, R2 (1+1) (Xylidyl Blue/ 2 point) 2 x 50ml + 2 x 50ml (Hitachi 911/912) MG3080 IN VITRO ALTELE RO/IVD-139-278-165 27-05-2010
Magnesium liquid / R1, R2 (1+1) (Xylidyl Blue/ 2 point) 2 x 100ml + 2 x 100ml (Hitachi 911/912)  MG3071 IN VITRO ALTELE RO/IVD-139-278-166 27-05-2010
Magnesium liquid / R1, R2 (1+1) (Xylidyl Blue/ 2 point) 4 x 58ml + 4 x 59ml (Hitachi 917) MG3090 IN VITRO ALTELE RO/IVD-139-278-167 27-05-2010
Magnesium liquid / R1, R2 (1+1) (Xylidyl Blue/ 2 point) 6 x 21ml + 6 x 21ml (Hitachi 917)  MG3072 IN VITRO ALTELE RO/IVD-139-278-168 27-05-2010
Pyruvate liquid / R1, R2 (10+1) (UV / endpoint) 1 x 100ml + 1 x 5ml + 1 x 5ml + Std. PY9030 IN VITRO ALTELE RO/IVD-139-278-169 27-05-2010
Potassium liquid / monoreagent (TPB / endpoint) 2 x 50ml + Std KA1033 IN VITRO ALTELE RO/IVD-139-278-170 27-05-2010
Potassium liquid / monoreagent (TPB / endpoint) 2 x 100ml + Std KA1034 IN VITRO ALTELE RO/IVD-139-278-171 27-05-2010
Total protein liquid / monoreagent (Biuret / endpoint) 4 x 100ml TP1020 IN VITRO ALTELE RO/IVD-139-278-172 27-05-2010
Total protein liquid / monoreagent (Biuret / endpoint) 1 x 1000ml TP1050 IN VITRO ALTELE RO/IVD-139-278-173 27-05-2010
Total protein liquid / R1, R2 (5+1) (Biuret / endpoint) 4 x 50ml + 2 x 20ml (Hitachi 911/912) TP2080 IN VITRO ALTELE RO/IVD-139-278-174 27-05-2010
Total protein liquid / R1, R2 (5+1) (Biuret / endpoint) 4 x 100ml + 2 x 40ml (Hitachi 911/912) TP2070 IN VITRO ALTELE RO/IVD-139-278-175 27-05-2010
Total protein liquid / R1, R2 (5+1) (Biuret / endpoint) 6 x 65ml + 4 x 20ml (Hitachi 917) TP2090 IN VITRO ALTELE RO/IVD-139-278-176 27-05-2010
Protein UL liquid / monoreagent (Coomassie / endpoint) 2 x 50ml + Std UP1033 IN VITRO ALTELE RO/IVD-139-278-177 27-05-2010
Protein UL liquid / monoreagent (Coomassie / endpoint) 2 x 100ml + Std UP1034 IN VITRO ALTELE RO/IVD-139-278-178 27-05-2010
Sodium liquid / R1, R2 (1+1) (Uranylthioglycolate / endpoint) 1 x 50ml + 1 x 50ml + Std NA3033 IN VITRO ALTELE RO/IVD-139-278-179 27-05-2010
Sodium liquid / R1, R2 (1+1) (Uranylthioglycolate / endpoint) 1 x 100ml + 1 x 100ml + Std NA3034 IN VITRO ALTELE RO/IVD-139-278-180 27-05-2010
Triglycerides liquid / monoreagent (GPO-PAP / endpoint) 2 x 50ml + Std TR1030 IN VITRO ALTELE RO/IVD-139-278-181 27-05-2010
Triglycerides liquid / monoreagent (GPO-PAP / endpoint) 4 x 100ml + Std TR1020 IN VITRO ALTELE RO/IVD-139-278-182 27-05-2010
Triglycerides liquid / monoreagent (GPO-PAP / endpoint) 4 x 50ml (Hitachi 911/912) TR1080 IN VITRO ALTELE RO/IVD-139-278-183 27-05-2010
Triglycerides liquid / monoreagent (GPO-PAP / endpoint) 4 x 100ml (Hitachi 911/912) TR1071 IN VITRO ALTELE RO/IVD-139-278-184 27-05-2010
Triglycerides liquid / monoreagent (GPO-PAP / endpoint) 6 x 65ml (Hitachi 917) TR1072 IN VITRO ALTELE RO/IVD-139-278-185 27-05-2010
Urea IN liquid / R1, R2 (50+1) (Urease Indic. / 2 point blanc / PLW) 4 x 50ml + 1 x 4,5ml + Std UR9023 IN VITRO ALTELE RO/IVD-139-278-186 27-05-2010
Urea IN liquid / R1, R2 (50+1) (Urease Indic. / 2 point blanc / PLW) 4 x 100ml + 1 x 8,5ml + Std UR9024 IN VITRO ALTELE RO/IVD-139-278-187 27-05-2010
Urea UV liquid / R1, R2 (5+1) (GLDH / 2 point) 2 x 50ml + 1 x 20ml + Std UR2030 IN VITRO ALTELE RO/IVD-139-278-188 27-05-2010
Urea UV liquid / R1, R2 (5+1) (GLDH / 2 point) 4 x 100ml + 2 x 40ml + Std UR2040 IN VITRO ALTELE RO/IVD-139-278-189 27-05-2010
Urea UV liquid / R1, R2 (5+1) (GLDH / 2 point) 4 x 100ml + 4 x 20ml (Hitachi 911/912) UR2070 IN VITRO ALTELE RO/IVD-139-278-190 27-05-2010
Urea UV liquid / R1, R2 (5+3) (GLDH / 2 point) 4 x 50ml + 3 x 40ml (Hitachi 911/912) UR7080 IN VITRO ALTELE RO/IVD-139-278-191 27-05-2010
Urea UV liquid / R1, R2 (5+3) (GLDH / 2 point) 4 x 100ml + 3 x 80ml (Hitachi 911/912) UR7070 IN VITRO ALTELE RO/IVD-139-278-192 27-05-2010
Urea UV liquid / R1, R2 (5+3) (GLDH / 2 point) 4 x 66ml + 4 x 43ml (Hitachi 917) UR7090 IN VITRO ALTELE RO/IVD-139-278-193 27-05-2010
Zinc liquid / monoreagent (5-Br PAPS / endpoint) 2 x 50ml + Std ZN1030 IN VITRO ALTELE RO/IVD-139-278-194 27-05-2010
ORTEZA DE INCHEIETURA MAINII-MANA CARPIERA SIMPLA 4X.S-543 CLASA I RO/I-112-203-13 03-06-2010
ORTEZA DE INCHEIETURA MAINII-MANA CARPIERA CU ATELA 4X.O-151 CLASA I RO/I-112-203-14 03-06-2010
ORTEZA CERVICO-TORACICA HAM DE MEMORIE 4X.H-21 CLASA I RO/I-112-203-15 03-06-2010
ORTEZA CORECTOARE DE STATICA PICIORULUI HALLUX-VALGUS, DE ZI 4O.A-21 CLASA I RO/I-112-203-16 03-06-2010
LAVAJ NAZAL, BIOFLU® CLASA I RO/I-107-279-01 09-06-2010 anexa 1/20.03.2012; nu mai sunt introduse pe piata ca DM/28.07.2026
PROTEZA DE COAPSA PILON I-CP-7 LA COMANDA RO/C-057-100-25 12-07-2010
PROTEZA DE COAPSA DIN PLASTIC I-CPL-7 LA COMANDA RO/C-057-100-26 12-07-2010
PROTEZA DE COAPSA CU VACUUM I-CV-8 LA COMANDA RO/C-057-100-27 12-07-2010

*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