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 23.04.2024
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Denumire dispozitiv Tip Clasa Cod înregistrare Producator Reprezentant autorizat Data Observații
HbA1c Enzymatic Control Set/Set Control HbA1c Enzimatic 2 x 0.5 ml IN VITRO ALTELE RO_IVD_166_994_27 SC VITROMED SRL - 05-05-2022
TEST RAPID TOXICOLOGIE SALIVA - PANEL 6 DOA AMP BZO COC THC MET OPI CASETA IN VITRO ALTELE RO_IVD_414_995_01 SC STORK MEDICAL SRL - 09-05-2022
KIT MULTIPLEX (q)RT-SAB_COMBO(X) PENTRU DETECTIA SARS-COV-2, INFLUENZA A SI INFLUENZA B PENTRU 50 DE REACTII IN VITRO ALTELE RO_IVD_009_996_01 SC DDS DIAGNOSTIC SRL 11-05-2022
KIT MULTIPLEX (q)RT-SAB_COMBO(X) PENTRU DETECTIA SARS-COV-2, INFLUENZA A SI INFLUENZA B PENTRU 100 DE REACTII IN VITRO ALTELE RO_IVD_009_996_02 SC DDS DIAGNOSTIC SRL 11-05-2022
KIT MULTIPLEX (q)RT-SAB_COMBO(X) PENTRU DETECTIA SARS-COV-2, INFLUENZA A SI INFLUENZA B PENTRU 200 DE REACTII IN VITRO ALTELE RO_IVD_009_996_03 SC DDS DIAGNOSTIC SRL 11-05-2022
KIT MULTIPLEX (q)RT-SAB_COMBO(X) PENTRU DETECTIA SARS-COV-2, INFLUENZA A SI INFLUENZA B PENTRU 500 DE REACTII IN VITRO ALTELE RO_IVD_009_996_04 SC DDS DIAGNOSTIC SRL 11-05-2022
URIC ACID LS– ACID URIC LS 4 x 40 + 4 x 10 ml IN VITRO ALTELE RO_IVD_166_997_01 SC VITROMED SRL - 12-05-2022
URIC ACID LS– ACID URIC LS 4 x 40 + 4 x 10 ml IN VITRO ALTELE RO_IVD_166_997_02 SC VITROMED SRL - 12-05-2022
URIC ACID LS– ACID URIC LS 4 x 32 + 4 x 8 ml IN VITRO ALTELE RO_IVD_166_997_03 SC VITROMED SRL - 12-05-2022
URIC ACID LS– ACID URIC LS 4 x 40 + 4 x 10 ml IN VITRO ALTELE RO_IVD_166_997_04 SC VITROMED SRL - 12-05-2022
URIC ACID LS– ACID URIC LS 4 x 40 + 4 x 10 ml IN VITRO ALTELE RO_IVD_166_997_05 SC VITROMED SRL - 12-05-2022
URIC ACID LS– ACID URIC LS 4 x 40 + 4 x 10 ml IN VITRO ALTELE RO_IVD_166_997_06 SC VITROMED SRL - 12-05-2022
URIC ACID LS– ACID URIC LS 4 x 40 + 4 x 10 ml IN VITRO ALTELE RO_IVD_166_997_07 SC VITROMED SRL - 12-05-2022
URIC ACID LS– ACID URIC LS 4 x 40 + 4 x 10 ml IN VITRO ALTELE RO_IVD_166_997_08 SC VITROMED SRL - 12-05-2022
AMYLASE LS- AMILAZA LS 4 x 50 ml IN VITRO ALTELE RO_IVD_166_997_09 SC VITROMED SRL - 12-05-2022
AMYLASE LS- AMILAZA LS 2 x 100 ml IN VITRO ALTELE RO_IVD_166_997_10 SC VITROMED SRL - 12-05-2022
AMYLASE LS- AMILAZA LS 4 x 50 ml IN VITRO ALTELE RO_IVD_166_997_11 SC VITROMED SRL - 12-05-2022
AMYLASE LS- AMILAZA LS 4 x 50 ml IN VITRO ALTELE RO_IVD_166_997_12 SC VITROMED SRL - 12-05-2022
AMYLASE LS- AMILAZA LS 5 x 40 ml IN VITRO ALTELE RO_IVD_166_997_13 SC VITROMED SRL - 12-05-2022
AMYLASE LS- AMILAZA LS 4 x 50 ml IN VITRO ALTELE RO_IVD_166_997_14 SC VITROMED SRL - 12-05-2022
AMYLASE LS- AMILAZA LS 4 x 50 ml IN VITRO ALTELE RO_IVD_166_997_15 SC VITROMED SRL - 12-05-2022
AMYLASE LS- AMILAZA LS 4 x 50 ml IN VITRO ALTELE RO_IVD_166_997_16 SC VITROMED SRL - 12-05-2022
ALKALINE PHOSPHATASE LS - FOSFATAZA ALCALINA LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_17 SC VITROMED SRL - 12-05-2022
ALKALINE PHOSPHATASE LS - FOSFATAZA ALCALINA LS 2 x 80 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_18 SC VITROMED SRL - 12-05-2022
ALKALINE PHOSPHATASE LS - FOSFATAZA ALCALINA LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_19 SC VITROMED SRL - 12-05-2022
ALKALINE PHOSPHATASE LS - FOSFATAZA ALCALINA LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_20 SC VITROMED SRL - 12-05-2022
ALKALINE PHOSPHATASE LS - FOSFATAZA ALCALINA LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_21 SC VITROMED SRL - 12-05-2022
ALKALINE PHOSPHATASE LS - FOSFATAZA ALCALINA LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_22 SC VITROMED SRL - 12-05-2022
ALKALINE PHOSPHATASE LS - FOSFATAZA ALCALINA LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_23 SC VITROMED SRL - 12-05-2022
ALKALINE PHOSPHATASE LS - FOSFATAZA ALCALINA LS 2 x 80 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_24 SC VITROMED SRL - 12-05-2022
CALCIUM LS / CALCIU LS 6 x 60 ml IN VITRO ALTELE RO_IVD_166_997_25 SC VITROMED SRL - 12-05-2022
CALCIUM LS / CALCIU LS 5 x 40 ml IN VITRO ALTELE RO_IVD_166_997_26 SC VITROMED SRL - 12-05-2022
CALCIUM LS / CALCIU LS 8 x 50 ml IN VITRO ALTELE RO_IVD_166_997_27 SC VITROMED SRL - 12-05-2022
CALCIUM LS / CALCIU LS 4 x 100 ml IN VITRO ALTELE RO_IVD_166_997_28 SC VITROMED SRL - 12-05-2022
CALCIUM LS / CALCIU LS 4 x 100 ml IN VITRO ALTELE RO_IVD_166_997_29 SC VITROMED SRL - 12-05-2022
CALCIUM LS / CALCIU LS 8 x 50 ml IN VITRO ALTELE RO_IVD_166_997_30 SC VITROMED SRL - 12-05-2022
CALCIUM LS / CALCIU LS 8 x 50 ml IN VITRO ALTELE RO_IVD_166_997_31 SC VITROMED SRL - 12-05-2022
CALCIUM LS / CALCIU LS 5 x 80 ml IN VITRO ALTELE RO_IVD_166_997_32 SC VITROMED SRL - 12-05-2022
CK-MB LS / CK-MB LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_33 SC VITROMED SRL - 12-05-2022
CK-MB LS / CK-MB LS 2 x 80 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_34 SC VITROMED SRL - 12-05-2022
CK-MB LS / CK-MB LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_35 SC VITROMED SRL - 12-05-2022
CK-MB LS / CK-MB LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_36 SC VITROMED SRL - 12-05-2022
CK-MB LS / CK-MB LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_37 SC VITROMED SRL - 12-05-2022
CK-MB LS / CK-MB LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_38 SC VITROMED SRL - 12-05-2022
CK-MB LS / CK-MB LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_39 SC VITROMED SRL - 12-05-2022
CK-MB LS / CK-MB LS 2 x 80 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_40 SC VITROMED SRL - 12-05-2022
CK-NAC LS / CK-NAC LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_41 SC VITROMED SRL - 13-05-2022
CK-NAC LS / CK-NAC LS 2 x 80 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_42 SC VITROMED SRL - 13-05-2022
CK-NAC LS / CK-NAC LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_43 SC VITROMED SRL - 13-05-2022
CK-NAC LS / CK-NAC LS 4 x 40 + 2 x 20 ml IN VITRO ALTELE RO_IVD_166_997_44 SC VITROMED SRL - 13-05-2022

*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