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 08.10.2024
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Denumire dispozitiv Tip Clasa Cod înregistrare Producator Reprezentant autorizat Data Observații
TOTAL PROTEIN / biuret - PROTEINE TOTALE / biuret 5 x 80 ml IN VITRO ALTELE RO_IVD_166_984_103 SC VITROMED SRL - 06-01-2022
TOTAL PROTEIN / biuret - PROTEINE TOTALE / biuret 8 x 50 ml IN VITRO ALTELE RO_IVD_166_984_104 SC VITROMED SRL - 06-01-2022
TOTAL PROTEIN / biuret - PROTEINE TOTALE / biuret 5 x 40 ml IN VITRO ALTELE RO_IVD_166_984_105 SC VITROMED SRL - 06-01-2022
TOTAL PROTEIN / biuret - PROTEINE TOTALE / biuret 8 x 50 ml IN VITRO ALTELE RO_IVD_166_984_106 SC VITROMED SRL - 06-01-2022
TRIGLYCERIDES / GPO-PAP - TRIGLICERIDE / GPO-PAP 2 x 50 ml IN VITRO ALTELE RO_IVD_166_984_107 SC VITROMED SRL - 06-01-2022
TRIGLYCERIDES / GPO-PAP - TRIGLICERIDE / GPO-PAP 2 x 60 ml IN VITRO ALTELE RO_IVD_166_984_108 SC VITROMED SRL - 06-01-2022
TRIGLYCERIDES / GPO-PAP - TRIGLICERIDE / GPO-PAP 5 x 80 ml IN VITRO ALTELE RO_IVD_166_984_109 SC VITROMED SRL - 06-01-2022
TRIGLYCERIDES / GPO-PAP - TRIGLICERIDE / GPO-PAP 8 x 50 ml IN VITRO ALTELE RO_IVD_166_984_110 SC VITROMED SRL - 06-01-2022
TRIGLYCERIDES / GPO-PAP - TRIGLICERIDE / GPO-PAP 5 x 40 ml IN VITRO ALTELE RO_IVD_166_984_111 SC VITROMED SRL - 06-01-2022
TRIGLYCERIDES / GPO-PAP - TRIGLICERIDE / GPO-PAP 8 x 50 ml IN VITRO ALTELE RO_IVD_166_984_112 SC VITROMED SRL - 06-01-2022
UREA / UV - UREE / UV 2 x 40 + 1 x 20 ml IN VITRO ALTELE RO_IVD_166_984_113 SC VITROMED SRL - 06-01-2022
UREA / UV - UREE / UV 3 x 60 + 3 x 15 ml IN VITRO ALTELE RO_IVD_166_984_114 SC VITROMED SRL - 06-01-2022
UREA / UV - UREE / UV 4 x 80 + 4 x 20 ml IN VITRO ALTELE RO_IVD_166_984_115 SC VITROMED SRL - 06-01-2022
UREA / UV - UREE / UV 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_984_116 SC VITROMED SRL - 06-01-2022
UREA / UV - UREE / UV 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_984_117 SC VITROMED SRL - 06-01-2022
URIC ACID / uricase- PAP– ACID URIC / uricaza PAP 2 x 60 ml IN VITRO ALTELE RO_IVD_166_984_118 SC VITROMED SRL - 06-01-2022
URIC ACID / uricase- PAP– ACID URIC / uricaza PAP 5 x 80 ml IN VITRO ALTELE RO_IVD_166_984_119 SC VITROMED SRL - 06-01-2022
URIC ACID / uricase- PAP– ACID URIC / uricaza PAP 8 x 50 ml IN VITRO ALTELE RO_IVD_166_984_120 SC VITROMED SRL - 06-01-2022
URIC ACID / uricase- PAP– ACID URIC / uricaza PAP 5 x 40 ml IN VITRO ALTELE RO_IVD_166_984_121 SC VITROMED SRL - 06-01-2022
URIC ACID / uricase- PAP– ACID URIC / uricaza PAP 8 x 50 ml IN VITRO ALTELE RO_IVD_166_984_122 SC VITROMED SRL - 06-01-2022
Acid Cuvette Clean (for ILAB600/650) - Solutie acida de spalare (pentru ILAB600/650) 1 x 1000 ml IN VITRO ALTELE RO_IVD_166_984_123 SC VITROMED SRL - 06-01-2022
Alkaline Cuvette Clean (for ILAB600/650) - Solutie alcalina de spalare (pentru ILAB600/650) 1 x 1000 ml IN VITRO ALTELE RO_IVD_166_984_124 SC VITROMED SRL - 06-01-2022
Alkaline-Clean (for URIT and PPC PKL) - Solutie alcalina de spalare ( pentru URIT si PPC PKL) 1 x 1000 ml IN VITRO ALTELE RO_IVD_166_984_125 SC VITROMED SRL - 06-01-2022
ANTI-STREPTOLYSIN (O) / turbidimetric immunoassay - ANTI-STREPTOLIZINA (O) / reactie imunoturbidimetrica 2 x 33 + 2 x 7 ml IN VITRO ALTELE RO_IVD_166_985_01 SC VITROMED SRL - 18-01-2022
ANTI-STREPTOLYSIN (O) / turbidimetric immunoassay - ANTI-STREPTOLIZINA (O) / reactie imunoturbidimetrica 2 x 60 + 1 x 20 ml IN VITRO ALTELE RO_IVD_166_985_02 SC VITROMED SRL - 18-01-2022
ANTI-STREPTOLYSIN (O) / turbidimetric immunoassay - ANTI-STREPTOLIZINA (O) / reactie imunoturbidimetrica 1 x 60 + 1 x 10 ml IN VITRO ALTELE RO_IVD_166_985_03 SC VITROMED SRL - 18-01-2022
ANTI-STREPTOLYSIN (O) / turbidimetric immunoassay - ANTI-STREPTOLIZINA (O) / reactie imunoturbidimetrica 2 x 30 + 1 x 10 ml IN VITRO ALTELE RO_IVD_166_985_04 SC VITROMED SRL - 18-01-2022
ANTI-STREPTOLYSIN (O) / turbidimetric immunoassay - ANTI-STREPTOLIZINA (O) / reactie imunoturbidimetrica 2 x 30 + 1 x 10 ml IN VITRO ALTELE RO_IVD_166_985_05 SC VITROMED SRL - 18-01-2022
COMPLEMENT C3 / turbidimetric immunoassay - COMPLEMENT C3 / reactie imunoturbidimetrica 2 x 30 + 1 x 9 ml IN VITRO ALTELE RO_IVD_166_985_06 SC VITROMED SRL - 18-01-2022
COMPLEMENT C3 / turbidimetric immunoassay - COMPLEMENT C3 / reactie imunoturbidimetrica 2 x 42 + 2 x 7 ml IN VITRO ALTELE RO_IVD_166_985_07 SC VITROMED SRL - 18-01-2022
COMPLEMENT C3 / turbidimetric immunoassay - COMPLEMENT C3 / reactie imunoturbidimetrica 2 x 30 + 1 x 9 ml IN VITRO ALTELE RO_IVD_166_985_08 SC VITROMED SRL - 18-01-2022
COMPLEMENT C3 / turbidimetric immunoassay - COMPLEMENT C3 / reactie imunoturbidimetrica 2 x 30 + 1 x 9 ml IN VITRO ALTELE RO_IVD_166_985_09 SC VITROMED SRL - 18-01-2022
COMPLEMENT C3 / turbidimetric immunoassay - COMPLEMENT C3 / reactie imunoturbidimetrica 1 x 60 + 1 x 9 ml IN VITRO ALTELE RO_IVD_166_985_10 SC VITROMED SRL - 18-01-2022
COMPLEMENT C4 / turbidimetric immunoassay - COMPLEMENT C4 / reactie imunoturbidimetrica 2 x 30 + 1 x 9 ml IN VITRO ALTELE RO_IVD_166_985_11 SC VITROMED SRL - 18-01-2022
COMPLEMENT C4 / turbidimetric immunoassay - COMPLEMENT C4 / reactie imunoturbidimetrica 2 x 32 + 2 x 6 ml IN VITRO ALTELE RO_IVD_166_985_12 SC VITROMED SRL - 18-01-2022
COMPLEMENT C4 / turbidimetric immunoassay - COMPLEMENT C4 / reactie imunoturbidimetrica 2 x 30 + 1 x 9 ml IN VITRO ALTELE RO_IVD_166_985_13 SC VITROMED SRL - 18-01-2022
COMPLEMENT C4 / turbidimetric immunoassay - COMPLEMENT C4 / reactie imunoturbidimetrica 2 x 30 + 1 x 9 ml IN VITRO ALTELE RO_IVD_166_985_14 SC VITROMED SRL - 18-01-2022
COMPLEMENT C4 / turbidimetric immunoassay - COMPLEMENT C4 / reactie imunoturbidimetrica 1 x 60 + 1 x 9 ml IN VITRO ALTELE RO_IVD_166_985_15 SC VITROMED SRL - 18-01-2022
RHEUMATOID FACTOR / turbidimetric immunoassay - FACTOR REAUMATOID / reactie imunoturbidimetrica 1 x 33 + 1 x 7 ml IN VITRO ALTELE RO_IVD_166_985_16 SC VITROMED SRL - 18-01-2022
RHEUMATOID FACTOR / turbidimetric immunoassay - FACTOR REAUMATOID / reactie imunoturbidimetrica 2 x 50 + 1 x 20 ml IN VITRO ALTELE RO_IVD_166_985_17 SC VITROMED SRL - 18-01-2022
RHEUMATOID FACTOR / turbidimetric immunoassay - FACTOR REAUMATOID / reactie imunoturbidimetrica 2 x 25 + 1 x 10 ml IN VITRO ALTELE RO_IVD_166_985_18 SC VITROMED SRL - 18-01-2022
RHEUMATOID FACTOR / turbidimetric immunoassay - FACTOR REAUMATOID / reactie imunoturbidimetrica 1 x 50 + 1 x 10 ml IN VITRO ALTELE RO_IVD_166_985_19 SC VITROMED SRL - 18-01-2022
RHEUMATOID FACTOR / turbidimetric immunoassay - FACTOR REAUMATOID / reactie imunoturbidimetrica 1 x 50 + 1 x 10 ml IN VITRO ALTELE RO_IVD_166_985_20 SC VITROMED SRL - 18-01-2022
Ferritin / turbidimetric immunoassay - Feritina / reactie imunoturbidimetrica 1 x 40 + 1 x 10 ml + 1 x 3 ml Cal. + 1 x 2 ml Con. IN VITRO ALTELE RO_IVD_166_985_21 SC VITROMED SRL - 18-01-2022
Ferritin / turbidimetric immunoassay - Feritina / reactie imunoturbidimetrica 1 x 40 + 1 x 10 ml + 1 x 3 ml Cal. + 1 x 2 ml Con. IN VITRO ALTELE RO_IVD_166_985_22 SC VITROMED SRL - 18-01-2022
VITRO-CON HbA1c / HbA1c Control set (low+high) - VITRO-CON HbA1c / HbA1c Control set (nivel scazut + nivel crescut) 2 x 0.5 ml IN VITRO ALTELE RO_IVD_166_985_23 SC VITROMED SRL - 18-01-2022
VITRO-STANDARD HbA1c / Standard set 5 levels - VITRO-STANDARD HbA1c / Standard set 5 nivele 1 x 2 + 4 x 0.5 ml IN VITRO ALTELE RO_IVD_166_985_24 SC VITROMED SRL - 18-01-2022
HbA1c / turbidimetric immunoassay - HbA1c / reactie imunoturbidimetrica 1 x 50 + 1 x 10 ml IN VITRO ALTELE RO_IVD_166_985_25 SC VITROMED SRL - 18-01-2022
HbA1c / turbidimetric immunoassay - HbA1c / reactie imunoturbidimetrica 2 x 50 + 1 x 20 ml IN VITRO ALTELE RO_IVD_166_985_26 SC VITROMED SRL - 18-01-2022
Ig A / turbidimetric immunoassay - Ig A / reactie imunoturbidimetrica 2 x 35 + 1 x 9 ml IN VITRO ALTELE RO_IVD_166_985_27 SC VITROMED SRL - 18-01-2022

*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