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
Uric acid liquid / monoreagent (uricase PAP / endpoint) 4 x 50ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-03 SC MG DIAGNOSTIC SRL - 27-05-2010
Uric acid liquid / monoreagent (uricase PAP / endpoint) 4 x 100ml  (Hitachi 911/912)  IN VITRO ALTELE RO/IVD-139-278-04 SC MG DIAGNOSTIC SRL - 27-05-2010
Uric acid liquid / R1, R2 (5+1) (uricase PAP / endpoint) 2 x 50ml + 1 x 20ml + Std IN VITRO ALTELE RO/IVD-139-278-05 SC MG DIAGNOSTIC SRL - 27-05-2010
Uric acid liquid / R1, R2 (5+1) (uricase PAP / endpoint) 4 x 100ml + 2 x 40ml + Std IN VITRO ALTELE RO/IVD-139-278-06 SC MG DIAGNOSTIC SRL - 27-05-2010
Uric acid liquid / R1, R2 (5+1) (uricase PAP / endpoint) 4 x 50ml +  2 x 20ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-07 SC MG DIAGNOSTIC SRL - 27-05-2010
Uric acid liquid / R1, R2 (5+1) (uricase PAP / endpoint) 4 x 100ml + 4 x 20ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-08 SC MG DIAGNOSTIC SRL - 27-05-2010
Uric acid liquid / R1, R2 (5+1) (uricase PAP / endpoint) 6 x 66ml + 6 x 16ml (Hitachi 917) IN VITRO ALTELE RO/IVD-139-278-09 SC MG DIAGNOSTIC SRL - 27-05-2010
Uric acid liquid / R1, R2 (5+1) (uricase PAP / endpoint) 4 x 66ml + 4 x 16ml (Hitachi 917)  IN VITRO ALTELE RO/IVD-139-278-10 SC MG DIAGNOSTIC SRL - 27-05-2010
Albumin liquid / monoreagent (BCG / endpoint) 4 x 100ml + std. IN VITRO ALTELE RO/IVD-139-278-11 SC MG DIAGNOSTIC SRL - 27-05-2010
Albumin liquid / monoreagent (BCG / endpoint) 1 x 1000ml + std. IN VITRO ALTELE RO/IVD-139-278-12 SC MG DIAGNOSTIC SRL - 27-05-2010
Albumin liquid / monoreagent (BCG / endpoint) 2 x 500ml + std. IN VITRO ALTELE RO/IVD-139-278-13 SC MG DIAGNOSTIC SRL - 27-05-2010
Albumin liquid / monoreagent (BCG / endpoint) 4 x 50ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-14 SC MG DIAGNOSTIC SRL - 27-05-2010
Albumin liquid / monoreagent (BCG / endpoint) 4 x 100ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-15 SC MG DIAGNOSTIC SRL - 27-05-2010
Amylase liquid / R1, R2 (5+1) (EPS / kinetic)  4 x 25ml + 2 x 10ml IN VITRO ALTELE RO/IVD-139-278-16 SC MG DIAGNOSTIC SRL - 27-05-2010
Amylase liquid / R1, R2 (5+1) (EPS / kinetic)  2 x 100ml + 2 x 20ml IN VITRO ALTELE RO/IVD-139-278-17 SC MG DIAGNOSTIC SRL - 27-05-2010
Amylase liquid / R1, R2 (5+1) (EPS / kinetic)  4 x 50ml + 2 x 20ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-18 SC MG DIAGNOSTIC SRL - 27-05-2010
Amylase liquid / R1, R2 (5+1) (EPS / kinetic)  6 x 66ml + 6 x 16ml (Hitachi 917) IN VITRO ALTELE RO/IVD-139-278-19 SC MG DIAGNOSTIC SRL - 27-05-2010
Pancreatic amylase liquid / R1, R2 (5+1) (EPS IFCC / kinetic) 4 x 25ml + 2 x 10ml IN VITRO ALTELE RO/IVD-139-278-20 SC MG DIAGNOSTIC SRL - 27-05-2010
Pancreatic amylase liquid / R1, R2 (5+1) (EPS IFCC / kinetic) 4 x 50ml + 2 x 20ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-21 SC MG DIAGNOSTIC SRL - 27-05-2010
Pancreatic amylase liquid / R1, R2 (5+1) (EPS IFCC / kinetic) 6 x 66ml + 6 x 16ml (Hitachi 917) IN VITRO ALTELE RO/IVD-139-278-22 SC MG DIAGNOSTIC SRL - 27-05-2010
Ammonia liquid / R1, R2 (1+1) (GIDH / 2 point) 4 x 25ml + 1 x 10ml + 1 x 20ml + std IN VITRO ALTELE RO/IVD-139-278-23 SC MG DIAGNOSTIC SRL - 27-05-2010
Ammonia liquid / R1, R2 (1+1) (GIDH / 2 point) 2 x100ml + 2 x 10ml + 2 x 20ml + std IN VITRO ALTELE RO/IVD-139-278-24 SC MG DIAGNOSTIC SRL - 27-05-2010
Bilirubin Direct liquid / R1, R2 (50+1) (Jandrassik / 2 point) 2 x 50ml + 1 x 5ml IN VITRO ALTELE RO/IVD-139-278-25 SC MG DIAGNOSTIC SRL - 27-05-2010
Bilirubin Direct liquid / R1, R2 (50+1) (Jandrassik / 2 point) 2 x 100ml + 1 x 10ml  IN VITRO ALTELE RO/IVD-139-278-26 SC MG DIAGNOSTIC SRL - 27-05-2010
Bilirubin Direct liquid /R1, R2 (5+1) (DC / 2 point) 4 x 25ml + 2 x 10ml IN VITRO ALTELE RO/IVD-139-278-27 SC MG DIAGNOSTIC SRL - 27-05-2010
Bilirubin Direct liquid /R1, R2 (5+1) (DC / 2 point) 4 x 50ml + 2 x 20ml IN VITRO ALTELE RO/IVD-139-278-28 SC MG DIAGNOSTIC SRL - 27-05-2010
Bilirubin Direct liquid /R1, R2 (5+1) (DC / 2 point) 4 x 50ml + 2 x 20ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-29 SC MG DIAGNOSTIC SRL - 27-05-2010
Bilirubin Direct liquid /R1, R2 (5+1) (DC / 2 point) 5 x 18ml + 5 x 5ml (Hitachi 917)  IN VITRO ALTELE RO/IVD-139-278-30 SC MG DIAGNOSTIC SRL - 27-05-2010
Bilirubin Total liquid / R1, R2 (1+1) (DCA / endpoint) 2 x 50ml + 2 x 50ml + 2 x 100ml  IN VITRO ALTELE RO/IVD-139-278-31 SC MG DIAGNOSTIC SRL - 27-05-2010
Bilirubin Total liquid R1, R2 (5+1) (DC / endpoint) 4 x 25ml + 2 x 10ml IN VITRO ALTELE RO/IVD-139-278-32 SC MG DIAGNOSTIC SRL - 27-05-2010
Bilirubin Total liquid R1, R2 (5+1) (DC / endpoint) 4 x 50ml + 2 x 20ml IN VITRO ALTELE RO/IVD-139-278-33 SC MG DIAGNOSTIC SRL - 27-05-2010
Bilirubin Total liquid R1, R2 (5+1) (DC / endpoint) 4 x 50ml + 2 x 20ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-34 SC MG DIAGNOSTIC SRL - 27-05-2010
Bilirubin Total liquid R1, R2 (5+1) (DC / endpoint) 6 x 62ml + 6 x 19ml (Hitachi 917) IN VITRO ALTELE RO/IVD-139-278-35 SC MG DIAGNOSTIC SRL - 27-05-2010
Bilirubin Total/Direct liquid (R1, R2, R3) (Jandrassik / endpoint) 1 x 55ml + 1 x 12ml + 4 x 50ml  IN VITRO ALTELE RO/IVD-139-278-36 SC MG DIAGNOSTIC SRL - 27-05-2010
Calcium liquid / monoreagent (Arsenazo / endpoint) 2 x 100ml + Std. IN VITRO ALTELE RO/IVD-139-278-37 SC MG DIAGNOSTIC SRL - 27-05-2010
Calcium liquid / monoreagent (Arsenazo / endpoint) 4 x 50ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-38 SC MG DIAGNOSTIC SRL - 27-05-2010
Calcium liquid / monoreagent (Arsenazo / endpoint) 4 x 100ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-39 SC MG DIAGNOSTIC SRL - 27-05-2010
Calcium liquid / R1, R2 (5+2) (CPC / endpoint) 2 x 50ml + 2 x 20ml + Std IN VITRO ALTELE RO/IVD-139-278-40 SC MG DIAGNOSTIC SRL - 27-05-2010
Calcium liquid / R1, R2 (5+2) (CPC / endpoint) 2 x 100ml + 1 x 80ml + Std IN VITRO ALTELE RO/IVD-139-278-41 SC MG DIAGNOSTIC SRL - 27-05-2010
Calcium liquid / R1, R2 (5+2) (CPC / endpoint) 4 x 50ml + 4 x 20ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-42 SC MG DIAGNOSTIC SRL - 27-05-2010
Calcium liquid / R1, R2 (5+2) (CPC / endpoint) 4 x 100ml + 4 x 40ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-43 SC MG DIAGNOSTIC SRL - 27-05-2010
Calcium liquid / R1, R2 (5+2) (CPC / endpoint) 4 x 63ml + 4 x 29ml (Hitachi 917) IN VITRO ALTELE RO/IVD-139-278-44 SC MG DIAGNOSTIC SRL - 27-05-2010
CK-MB liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 25ml + 2 x 10ml IN VITRO ALTELE RO/IVD-139-278-45 SC MG DIAGNOSTIC SRL - 27-05-2010
CK-MB liquid / R1, R2 (5+1) (DGKC / kinetic) 2 x 100ml + 2 x 20ml IN VITRO ALTELE RO/IVD-139-278-46 SC MG DIAGNOSTIC SRL - 27-05-2010
CK-MB liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 50ml + 2 x 20ml (Hitachi 911/912)  IN VITRO ALTELE RO/IVD-139-278-47 SC MG DIAGNOSTIC SRL - 27-05-2010
CK-MB liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 100ml + 4 x 20ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-48 SC MG DIAGNOSTIC SRL - 27-05-2010
CK-MB liquid / R1, R2 (5+1) (DGKC / kinetic) 4 x 22ml + 2 x 10ml (Hitachi 917)  IN VITRO ALTELE RO/IVD-139-278-49 SC MG DIAGNOSTIC SRL - 27-05-2010
CK-NAC liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 25ml + 2 x 10ml IN VITRO ALTELE RO/IVD-139-278-50 SC MG DIAGNOSTIC SRL - 27-05-2010
CK-NAC liquid / R1, R2 (5+1) (IFCC / kinetic) 2 x 100ml + 2 x 20ml IN VITRO ALTELE RO/IVD-139-278-51 SC MG DIAGNOSTIC SRL - 27-05-2010
CK-NAC liquid / R1, R2 (5+1) (IFCC / kinetic) 4 x 50ml + 2 x 20ml (Hitachi 911/912) IN VITRO ALTELE RO/IVD-139-278-52 SC MG DIAGNOSTIC SRL - 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