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 26.11.2024
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Denumire dispozitiv Tip 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) IN VITRO ALTELE RO/IVD-139-278-153 SC MG DIAGNOSTIC SRL - 27-05-2010
LDL Precipitation liquid / monoreagent (Heparine / additional reagent) 2 x 100ml  IN VITRO ALTELE RO/IVD-139-278-154 SC MG DIAGNOSTIC SRL - 27-05-2010
LDL Direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 4 x 25ml + 2 x 17ml IN VITRO ALTELE RO/IVD-139-278-155 SC MG DIAGNOSTIC SRL - 27-05-2010
LDL Direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 3 x 50ml + 1 x 50ml IN VITRO ALTELE RO/IVD-139-278-156 SC MG DIAGNOSTIC SRL - 27-05-2010
LDL Direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 3 x 50ml + 1 x 50ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-157 SC MG DIAGNOSTIC SRL - 27-05-2010
LDL Direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 3 x 100ml + 1 x 100ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-158 SC MG DIAGNOSTIC SRL - 27-05-2010
LDL Direct liquid / R1, R2 (3+1) (Immunoturb. / 2 point) 6 x 54ml + 6 x 20ml (Hitachi 917) IN VITRO ALTELE RO/IVD-139-278-159 SC MG DIAGNOSTIC SRL - 27-05-2010
Lipase F liquid / R1, R2 (4+1) (Colortest / 2 point) 4 x 25ml + 1 x 25ml  IN VITRO ALTELE RO/IVD-139-278-160 SC MG DIAGNOSTIC SRL - 27-05-2010
Lipase F liquid / R1, R2 (4+1) (Colortest / 2 point) 4 x 80ml + 4 x 20ml (Hitachi 911/912)  IN VITRO ALTELE RO/IVD-139-278-161 SC MG DIAGNOSTIC SRL - 27-05-2010
Magnesium liquid / monoreagent (Xylidyl Blue/ endpoint) 2 x 50ml +std. IN VITRO ALTELE RO/IVD-139-278-162 SC MG DIAGNOSTIC SRL - 27-05-2010
Magnesium liquid / monoreagent (Xylidyl Blue/ endpoint) 4 x 100ml + Std IN VITRO ALTELE RO/IVD-139-278-163 SC MG DIAGNOSTIC SRL - 27-05-2010
Magnesium liquid / monoreagent (Xylidyl Blue/ endpoint) 4 x 100ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-164 SC MG DIAGNOSTIC SRL - 27-05-2010
Magnesium liquid / R1, R2 (1+1) (Xylidyl Blue/ 2 point) 2 x 50ml + 2 x 50ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-165 SC MG DIAGNOSTIC SRL - 27-05-2010
Magnesium liquid / R1, R2 (1+1) (Xylidyl Blue/ 2 point) 2 x 100ml + 2 x 100ml (Hitachi 911/912)  IN VITRO ALTELE RO/IVD-139-278-166 SC MG DIAGNOSTIC SRL - 27-05-2010
Magnesium liquid / R1, R2 (1+1) (Xylidyl Blue/ 2 point) 4 x 58ml + 4 x 59ml (Hitachi 917) IN VITRO ALTELE RO/IVD-139-278-167 SC MG DIAGNOSTIC SRL - 27-05-2010
Magnesium liquid / R1, R2 (1+1) (Xylidyl Blue/ 2 point) 6 x 21ml + 6 x 21ml (Hitachi 917)  IN VITRO ALTELE RO/IVD-139-278-168 SC MG DIAGNOSTIC SRL - 27-05-2010
Pyruvate liquid / R1, R2 (10+1) (UV / endpoint) 1 x 100ml + 1 x 5ml + 1 x 5ml + Std. IN VITRO ALTELE RO/IVD-139-278-169 SC MG DIAGNOSTIC SRL - 27-05-2010
Potassium liquid / monoreagent (TPB / endpoint) 2 x 50ml + Std IN VITRO ALTELE RO/IVD-139-278-170 SC MG DIAGNOSTIC SRL - 27-05-2010
Potassium liquid / monoreagent (TPB / endpoint) 2 x 100ml + Std IN VITRO ALTELE RO/IVD-139-278-171 SC MG DIAGNOSTIC SRL - 27-05-2010
Total protein liquid / monoreagent (Biuret / endpoint) 4 x 100ml IN VITRO ALTELE RO/IVD-139-278-172 SC MG DIAGNOSTIC SRL - 27-05-2010
Total protein liquid / monoreagent (Biuret / endpoint) 1 x 1000ml IN VITRO ALTELE RO/IVD-139-278-173 SC MG DIAGNOSTIC SRL - 27-05-2010
Total protein liquid / R1, R2 (5+1) (Biuret / endpoint) 4 x 50ml + 2 x 20ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-174 SC MG DIAGNOSTIC SRL - 27-05-2010
Total protein liquid / R1, R2 (5+1) (Biuret / endpoint) 4 x 100ml + 2 x 40ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-175 SC MG DIAGNOSTIC SRL - 27-05-2010
Total protein liquid / R1, R2 (5+1) (Biuret / endpoint) 6 x 65ml + 4 x 20ml (Hitachi 917) IN VITRO ALTELE RO/IVD-139-278-176 SC MG DIAGNOSTIC SRL - 27-05-2010
Protein UL liquid / monoreagent (Coomassie / endpoint) 2 x 50ml + Std IN VITRO ALTELE RO/IVD-139-278-177 SC MG DIAGNOSTIC SRL - 27-05-2010
Protein UL liquid / monoreagent (Coomassie / endpoint) 2 x 100ml + Std IN VITRO ALTELE RO/IVD-139-278-178 SC MG DIAGNOSTIC SRL - 27-05-2010
Sodium liquid / R1, R2 (1+1) (Uranylthioglycolate / endpoint) 1 x 50ml + 1 x 50ml + Std IN VITRO ALTELE RO/IVD-139-278-179 SC MG DIAGNOSTIC SRL - 27-05-2010
Sodium liquid / R1, R2 (1+1) (Uranylthioglycolate / endpoint) 1 x 100ml + 1 x 100ml + Std IN VITRO ALTELE RO/IVD-139-278-180 SC MG DIAGNOSTIC SRL - 27-05-2010
Triglycerides liquid / monoreagent (GPO-PAP / endpoint) 2 x 50ml + Std IN VITRO ALTELE RO/IVD-139-278-181 SC MG DIAGNOSTIC SRL - 27-05-2010
Triglycerides liquid / monoreagent (GPO-PAP / endpoint) 4 x 100ml + Std IN VITRO ALTELE RO/IVD-139-278-182 SC MG DIAGNOSTIC SRL - 27-05-2010
Triglycerides liquid / monoreagent (GPO-PAP / endpoint) 4 x 50ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-183 SC MG DIAGNOSTIC SRL - 27-05-2010
Triglycerides liquid / monoreagent (GPO-PAP / endpoint) 4 x 100ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-184 SC MG DIAGNOSTIC SRL - 27-05-2010
Triglycerides liquid / monoreagent (GPO-PAP / endpoint) 6 x 65ml (Hitachi 917) IN VITRO ALTELE RO/IVD-139-278-185 SC MG DIAGNOSTIC SRL - 27-05-2010
Urea IN liquid / R1, R2 (50+1) (Urease Indic. / 2 point blanc / PLW) 4 x 50ml + 1 x 4,5ml + Std IN VITRO ALTELE RO/IVD-139-278-186 SC MG DIAGNOSTIC SRL - 27-05-2010
Urea IN liquid / R1, R2 (50+1) (Urease Indic. / 2 point blanc / PLW) 4 x 100ml + 1 x 8,5ml + Std IN VITRO ALTELE RO/IVD-139-278-187 SC MG DIAGNOSTIC SRL - 27-05-2010
Urea UV liquid / R1, R2 (5+1) (GLDH / 2 point) 2 x 50ml + 1 x 20ml + Std IN VITRO ALTELE RO/IVD-139-278-188 SC MG DIAGNOSTIC SRL - 27-05-2010
Urea UV liquid / R1, R2 (5+1) (GLDH / 2 point) 4 x 100ml + 2 x 40ml + Std IN VITRO ALTELE RO/IVD-139-278-189 SC MG DIAGNOSTIC SRL - 27-05-2010
Urea UV liquid / R1, R2 (5+1) (GLDH / 2 point) 4 x 100ml + 4 x 20ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-190 SC MG DIAGNOSTIC SRL - 27-05-2010
Urea UV liquid / R1, R2 (5+3) (GLDH / 2 point) 4 x 50ml + 3 x 40ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-191 SC MG DIAGNOSTIC SRL - 27-05-2010
Urea UV liquid / R1, R2 (5+3) (GLDH / 2 point) 4 x 100ml + 3 x 80ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-192 SC MG DIAGNOSTIC SRL - 27-05-2010
Urea UV liquid / R1, R2 (5+3) (GLDH / 2 point) 4 x 66ml + 4 x 43ml (Hitachi 917) IN VITRO ALTELE RO/IVD-139-278-193 SC MG DIAGNOSTIC SRL - 27-05-2010
Zinc liquid / monoreagent (5-Br PAPS / endpoint) 2 x 50ml + Std IN VITRO ALTELE RO/IVD-139-278-194 SC MG DIAGNOSTIC SRL - 27-05-2010
ORTEZA DE INCHEIETURA MAINII-MANA CARPIERA SIMPLA CLASA I RO/I-112-203-13 SC ORTOPROFIL PROD ROMANIA SRL 03-06-2010
ORTEZA DE INCHEIETURA MAINII-MANA CARPIERA CU ATELA CLASA I RO/I-112-203-14 SC ORTOPROFIL PROD ROMANIA SRL 03-06-2010
ORTEZA CERVICO-TORACICA HAM DE MEMORIE CLASA I RO/I-112-203-15 SC ORTOPROFIL PROD ROMANIA SRL 03-06-2010
ORTEZA CORECTOARE DE STATICA PICIORULUI HALLUX-VALGUS, DE ZI CLASA I RO/I-112-203-16 SC ORTOPROFIL PROD ROMANIA SRL 03-06-2010
LAVAJ NAZAL, BIOFLU® CLASA I RO/I-107-279-01 SC BIOFARM SA 09-06-2010 anexa 1/20.03.2012
PROTEZA DE COAPSA PILON LA COMANDA RO/C-057-100-25 SC PROTMED PROTETIKA SRL 12-07-2010
PROTEZA DE COAPSA DIN PLASTIC LA COMANDA RO/C-057-100-26 SC PROTMED PROTETIKA SRL 12-07-2010
PROTEZA DE COAPSA CU VACUUM LA COMANDA RO/C-057-100-27 SC PROTMED PROTETIKA SRL 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