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
CK-NAC liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 100ml + 4 x 20ml (Hitachi 911/912) CN2070 IN VITRO ALTELE RO/IVD-139-278-53 27-05-2010
CK-NAC liquid / R1, R2 (5+1) (IFCC / kinetic) 6 x 60ml + 6 x 15ml (Hitachi 917)  CN2090 IN VITRO ALTELE RO/IVD-139-278-54 27-05-2010
Chloride liquid / monoreagent (HgSCN / endpoint) 2 x 50ml + Std CL1030 IN VITRO ALTELE RO/IVD-139-278-55 27-05-2010
Chloride liquid / monoreagent (HgSCN / endpoint) 4 x 100ml + Std CL1020 IN VITRO ALTELE RO/IVD-139-278-56 27-05-2010
Cholesterol liquid / monoreagent (CHOD-PAP / endpoint) 2 x 50ml + Std CH1030 IN VITRO ALTELE RO/IVD-139-278-57 27-05-2010
Cholesterol liquid / monoreagent (CHOD-PAP / endpoint) 4 x 100ml + Std CH1020 IN VITRO ALTELE RO/IVD-139-278-58 27-05-2010
Cholesterol liquid / monoreagent (CHOD-PAP / endpoint) 2 x 500ml + Std CH1060 IN VITRO ALTELE RO/IVD-139-278-59 27-05-2010
Cholesterol liquid / monoreagent (CHOD-PAP / endpoint) 4 x 50ml (Hitachi 911/912) CH1080 IN VITRO ALTELE RO/IVD-139-278-60 27-05-2010
Cholesterol liquid / monoreagent (CHOD-PAP / endpoint) 4 x 100ml (Hitachi 911/912) CH1071 IN VITRO ALTELE RO/IVD-139-278-61 27-05-2010
Cholesterol liquid / monoreagent (CHOD-PAP / endpoint) 6 x 66ml (Hitachi 917) CH1072 IN VITRO ALTELE RO/IVD-139-278-62 27-05-2010
Cholinesterase R1liquid, R2 Lyo (R1,R2 (5+1) / BTCJ / kinetic) 4 x 50ml + 2 x 20ml (Hitachi 911/912) CE2080 IN VITRO ALTELE RO/IVD-139-278-63 27-05-2010
Creatinine liquid / R1, R2 (5+1) (Jaffe / 2 point) 5 x 50ml + 1 x 50ml + 1 x 10 Std CR2020 IN VITRO ALTELE RO/IVD-139-278-64 27-05-2010
Creatinine liquid / R1, R2 (5+1) (Jaffe / 2 point) 4 x 100ml + 2x 40ml + 1 x 10 Std CR2040 IN VITRO ALTELE RO/IVD-139-278-65 27-05-2010
Creatinine liquid / R1, R2 (5+1) (Jaffe / 2 point) 4 x 50ml + 2 x 20ml (Hitachi 911/912) CR2080 IN VITRO ALTELE RO/IVD-139-278-66 27-05-2010
Creatinine liquid / R1, R2 (5+1) (Jaffe / 2 point) 4 x 100ml + 4 x 20ml (Hitachi 911/912) CR2070 IN VITRO ALTELE RO/IVD-139-278-67 27-05-2010
Creatinine liquid / R1, R2 (5+1) (Jaffe / 2 point) 6 x 66ml + 6 x 16ml (Hitachi 917) CR2090 IN VITRO ALTELE RO/IVD-139-278-68 27-05-2010
Creatinine liquid / R1, R2 (2+1) (PAP / 2 point) 2 x 50ml + 1 x 50ml + 1 x 5 Std CR5030 IN VITRO ALTELE RO/IVD-139-278-69 27-05-2010
Creatinine liquid / R1, R2 (2+1) (PAP / 2 point) 4 x 50ml + 2 x 50ml (Hitachi 911/912) CR5080 IN VITRO ALTELE RO/IVD-139-278-70 27-05-2010
Creatinine liquid / R1, R2 (2+1) (PAP / 2 point) 4 x 100ml + 4 x 50ml (Hitachi 911/912) CR5070 IN VITRO ALTELE RO/IVD-139-278-71 27-05-2010
Creatinine liquid / R1, R2 (2+1) (PAP / 2 point) 4 x 64ml + 4 x 35ml (Hitachi 917) CR5090 IN VITRO ALTELE RO/IVD-139-278-72 27-05-2010
Copper liquid / monoreagent (Di Br PAESA / endpoint) 2 x 50ml + Std CO1030 IN VITRO ALTELE RO/IVD-139-278-73 27-05-2010
Iron liquid / R1, R2 (5+1) (Ferrene S / 2 point) 4 x 50ml + 2 x 20ml + A (Hitachi 911/912) IR2580 IN VITRO ALTELE RO/IVD-139-278-74 27-05-2010
Iron liquid / R1, R2 (5+1) (Ferrene S / 2 point) 4 x 100ml + 2 x 40ml + A (Hitachi 911/912)  IR2570 IN VITRO ALTELE RO/IVD-139-278-75 27-05-2010
Iron liquid / R1, R2 (25+1) (Ferrene S / 2 point) 4 x 50ml + 1 x 8ml + Std + A IR9020 IN VITRO ALTELE RO/IVD-139-278-76 27-05-2010
Iron liquid / R1, R2 (25+1) (Ferrene S / 2 point) 4 x 100ml + 1 x 16ml + Std + A IR9040 IN VITRO ALTELE RO/IVD-139-278-77 27-05-2010
Iron liquid / R1, R2 (5+1) (Ferrozine S/ 2 point) 2 x 50ml + 1 x 20ml + Std + A IR2430 IN VITRO ALTELE RO/IVD-139-278-78 27-05-2010
Iron liquid / R1, R2 (5+1) (Ferrozine S/ 2 point) 4 x 50ml + 2 x 20ml + A (Hitachi 911/912) IR2480 IN VITRO ALTELE RO/IVD-139-278-79 27-05-2010
Iron liquid / R1, R2 (5+1) (Ferrozine S/ 2 point) 4 x 100ml + 2 x 40ml + A (Hitachi 911/912) IR2470 IN VITRO ALTELE RO/IVD-139-278-80 27-05-2010
Iron liquid / R1, R2 (5+1) (Ferrozine S/ 2 point) 6 x 64ml + 6 x 16ml (Hitachi 917) IR2490 IN VITRO ALTELE RO/IVD-139-278-81 27-05-2010
Iron liquid monoreagent (Nitro PAPS / endpoint) 2 x 50ml + Std IR1030 IN VITRO ALTELE RO/IVD-139-278-82 27-05-2010
Iron liquid monoreagent (Nitro PAPS / endpoint) 4 x 100ml + Std IR1020 IN VITRO ALTELE RO/IVD-139-278-83 27-05-2010
Acid phosphatase lyo / monoreagent (a-NP / kinetic) 5 x 10ml + 1 x 50 Buffer + 1 x 25 Tr.  AC1030 IN VITRO ALTELE RO/IVD-139-278-84 27-05-2010
Alkaline phosphatase liquid / R1, R2 (5+1) (AMP IFCC / kinetic) 4 x 25ml + 2x10ml AP2110 IN VITRO ALTELE RO/IVD-139-278-85 27-05-2010
Alkaline phosphatase liquid / R1, R2 (5+1) (AMP IFCC / kinetic) 2 x 50ml + 1 x 20ml AP2130 IN VITRO ALTELE RO/IVD-139-278-86 27-05-2010
Alkaline phosphatase liquid / R1, R2 (5+1) (AMP IFCC / kinetic) 4 x 100ml + 2 x 40ml AP2140 IN VITRO ALTELE RO/IVD-139-278-87 27-05-2010
Alkaline phosphatase liquid / R1, R2 (5+1) (AMP IFCC / kinetic) 4 x 50ml + 2 x 20ml (Hitachi 911/912) AP2180 IN VITRO ALTELE RO/IVD-139-278-88 27-05-2010
Alkaline phosphatase liquid / R1, R2 (5+1) (AMP IFCC / kinetic) 4 x 100ml + 4 x 20ml (Hitachi 911/912)  AP2171  IN VITRO ALTELE RO/IVD-139-278-89 27-05-2010
Alkaline phosphatase liquid / R1, R2 (5+1) (AMP IFCC / kinetic) 4 x 67ml + 4 x 17ml (Hitachi917) AP2172 IN VITRO ALTELE RO/IVD-139-278-90 27-05-2010
Alkaline phosphatase liquid / R1, R2 (5+1) (AMP IFCC / kinetic) 6 x 66ml + 6 x 16ml (Hitachi917)  AP2190 IN VITRO ALTELE RO/IVD-139-278-91 27-05-2010
Alkaline phosphatase liquid / R1, R2 (5+1) (DEA DGKC / kinetic) 4 x 25ml + 2 x 10ml AP2210 IN VITRO ALTELE RO/IVD-139-278-92 27-05-2010
Alkaline phosphatase liquid / R1, R2 (5+1) (DEA DGKC / kinetic) 2 x 50ml + 1x 20ml AP2230 IN VITRO ALTELE RO/IVD-139-278-93 27-05-2010
Alkaline phosphatase liquid / R1, R2 (5+1) (DEA DGKC / kinetic) 4 x 100ml + 2 x 40ml AP2240 IN VITRO ALTELE RO/IVD-139-278-94 27-05-2010
Alkaline phosphatase liquid / R1, R2 (5+1) (DEA DGKC / kinetic) 4 x 50ml + 2 x 20ml (Hitachi 911/912) AP2280 IN VITRO ALTELE RO/IVD-139-278-95 27-05-2010
Alkaline phosphatase liquid / R1, R2 (5+1) (DEA DGKC / kinetic) 4 x 100ml + 4 x 20ml (Hitachi 911/912) AP2270 IN VITRO ALTELE RO/IVD-139-278-96 27-05-2010
Phosphorus UV liquid / monoreagent (NH4 molybdate / endpoint) 2 X 50ml + std. PH1030 IN VITRO ALTELE RO/IVD-139-278-97 27-05-2010
Phosphorus UV liquid / monoreagent (NH4 molybdate / endpoint) 4 x 50ml (Hitachi 911/912) PH1080 IN VITRO ALTELE RO/IVD-139-278-98 27-05-2010
Phosphorus UV liquid / monoreagent (NH4 molybdate / endpoint) 4 x 100ml (Hitachi 911/912) PH1070 IN VITRO ALTELE RO/IVD-139-278-99 27-05-2010
Phosphorus UV liquid / R1, R2 (2+1) (NH4 molybdate / endpoint) 4 x 63ml + 4 x 31ml (Hitachi 917)  PH5090 IN VITRO ALTELE RO/IVD-139-278-100 27-05-2010
γ-GT liquid / R1, R2 (5+1) (IFCC / kinetic) 2 x 50ml + 1 x 20ml GT2030 IN VITRO ALTELE RO/IVD-139-278-101 27-05-2010
γ-GT liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 100ml + 2 x 40ml GT2040 IN VITRO ALTELE RO/IVD-139-278-102 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