| CerTest Resischeck® Carbapenemases
82149920181 |
Carbapenemase-producing microorganisms |
III |
CERTEST BIOTEC, S.L. |
05/10/2026 |
Until 05/10/2036 |
| WANTAI anti-HBe ELISA
82149920180 |
Hepatitis B e antigen and antibody (HBeAg/anti-HBe) |
IV |
BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO., LTD |
28/09/2026 |
Until 28/09/2036 |
| WANTAI HBeAg ELISA
82149920179 |
Hepatitis B e antigen (HBeAg) |
IV |
BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO., LTD |
28/09/2026 |
Until 28/09/2036 |
| VIASURE Herpes virus 1, Herpes virus 2 & Varicella Zoster Virus Real Time PCR Detection Kit com Controle de Extração
82149920178 |
Combined parameters in one product - class III |
III |
CERTEST BIOTEC, S.L. |
21/09/2026 |
Until 21/09/2036 |
| Epstein Barr virus REAL-TIME PCR Detection Kit
82149920177 |
Epstein-Barr virus (EBV) nucleic acid |
IV |
DNA-TECHNOLOGY, RESEARCH & PRODUCTION |
20/07/2026 |
Until 20/07/2036 |
| T.vaginalis/N.gonorrhoeae/C.trachomatis Multiplex REAL TIME PCR Detection Kit – Tube
82149920176 |
Combined parameters in one product - class IV |
IV |
DNA-TECHNOLOGY, RESEARCH & PRODUCTION |
20/07/2026 |
Until 20/07/2036 |
| T.vaginalis/N.gonorrhoeae/C.trachomatis Multiplex REAL TIME PCR Detection Kit – Strip
82149920175 |
Combined parameters in one product - class IV |
IV |
DNA-TECHNOLOGY, RESEARCH & PRODUCTION |
20/07/2026 |
Until 20/07/2036 |
| VIASURE Herpes virus 1, Herpes virus 2 & Varicella Zoster Virus Real Time PCR Detection Kit (Tubos com Controle de Extração)
82149920174 |
Combined parameters in one product - class III |
III |
CERTEST BIOTEC, S.L. |
13/07/2026 |
Until 13/07/2036 |
| VIASURE SARS-CoV-2 Real Time PCR Detection Kit com Controle de Extração
82149920173 |
Coronavirus |
III |
CERTEST BIOTEC, S.L. |
06/07/2026 |
Until 06/07/2036 |
| VIASURE Herpes virus 1, Herpes virus 2 & Varicella Zoster Virus Real Time PCR Detection Kit Tubes
82149920172 |
Combined parameters in one product - class III |
III |
CERTEST BIOTEC, S.L. |
06/07/2026 |
Until 06/07/2036 |
| VIASURE SARS-CoV-2 Real Time PCR Detection Kit (Tubo com Controle de Extração)
82149920171 |
Coronavirus |
III |
CERTEST BIOTEC, S.L. |
22/06/2026 |
Until 22/06/2036 |
| VIASURE SARS-CoV-2 Real Time PCR Detection Kit Tubes
82149920170 |
Coronavirus |
III |
CERTEST BIOTEC, S.L. |
22/06/2026 |
Until 22/06/2036 |
| Artron COVID-19 and Flu A/B Antigen Test
82149920169 |
Combined parameters - respiratory panel |
III |
ARTRON LABORATORIES INC. |
08/06/2026 |
Until 08/06/2036 |
| Artron COVID-19 Antigen Test
82149920168 |
Coronavirus |
III |
ARTRON LABORATORIES INC. |
08/06/2026 |
Until 08/06/2036 |
| VIASURE BK virus q Real Time PCR Detection Kit (Tube)
82149920167 |
BK polyomavirus |
II |
CERTEST BIOTEC, S.L. |
25/05/2026 |
Valid |
| VIASURE BK virus q Real Time PCR Detection Kit
82149920166 |
BK polyomavirus |
II |
CERTEST BIOTEC, S.L. |
18/05/2026 |
Valid |
| Artron Hepatitis C Virus (HCV) Antibody Test
82149920165 |
Confirmatory antibody test for hepatitis C virus (anti-HCV) |
IV |
ARTRON LABORATORIES INC. |
11/05/2026 |
Until 11/05/2036 |
| Família CerTest Clostridium difficile antigen GDH
82149920164 |
Clostridium difficile (Clostridioides difficile) |
III |
CERTEST BIOTEC, S.L. |
11/05/2026 |
Until 11/05/2036 |
| Artron Cardiac Troponin I (cTnI) Test kit
82149920163 |
Troponin |
III |
ARTRON LABORATORIES INC. |
04/05/2026 |
Until 04/05/2036 |
| Artron Chagas Ab Rapid Test
82149920162 |
Trypanosoma cruzi total antibodies |
IV |
ARTRON LABORATORIES INC. |
04/05/2026 |
Until 04/05/2036 |
| HiPurA® Pre- filled Plates for Viral RNA Extraction (MB615MPF1611)
82149920161 |
Buffers, diluents and other solutions for laboratory analysis |
I |
HIMEDIA LABORATORIES PVT.LTD. |
16/03/2026 |
Valid |
| HiPurA® Pre- filled Cartridges for Viral RNA Extraction (MB615PC1611)
82149920160 |
Buffers, diluents and other solutions for laboratory analysis |
I |
HIMEDIA LABORATORIES PVT.LTD. |
16/03/2026 |
Valid |
| VIASURE ADV, CMV, EBV & PB19 Real Time PCR Detection Kit (Strip)
82149920159 |
Combined parameters in one product - class IV |
IV |
CERTEST BIOTEC, S.L. |
09/03/2026 |
Until 09/03/2036 |
| VIASURE Viral Meningitis Panel Real Time PCR com Controle de Extração
82149920158 |
Combined parameters in one product - class IV |
IV |
CERTEST BIOTEC, S.L. |
18/02/2026 |
Until 18/02/2036 |
| VIASURE Viral Meningitis Panel Real Time PCR
82149920157 |
Combined parameters in one product - class IV |
IV |
CERTEST BIOTEC, S.L. |
18/02/2026 |
Until 18/02/2036 |
| TANBead® Nucleic Acid Extraction Kit - M622
82149920156 |
Buffers, diluents and other solutions for laboratory analysis |
I |
TAIWAN ADVANCED NANOTECH INC. (TANBEAD) |
12/01/2026 |
Valid |
| CerTest H. pylori one step card test
82149920155 |
Helicobacter pylori |
II |
CERTEST BIOTEC, S.L. |
12/01/2026 |
Valid |
| FAMÍLIA PREP-NA, NA PLUS DNA/RNA Extraction Kit
82149920154 |
Buffers, diluents and other solutions for laboratory analysis |
I |
DNA-TECHNOLOGY, RESEARCH & PRODUCTION |
12/01/2026 |
Valid |
| CerTest H. pylori one step card test – Positive Control
82149920153 |
Helicobacter pylori |
II |
CERTEST BIOTEC, S.L. |
12/01/2026 |
Valid |
| InstaDNA™ Penta Card
82149920152 |
Container or material for collection, storage or transport of biological samples |
I |
HIMEDIA LABORATORIES PVT.LTD. |
05/01/2026 |
Valid |
| InstaDNA™ Quadri Card
82149920151 |
Container or material for collection, storage or transport of biological samples |
I |
HIMEDIA LABORATORIES PVT.LTD. |
05/01/2026 |
Valid |
| InstaDNA™ Cards
82149920150 |
Container or material for collection, storage or transport of biological samples |
I |
HIMEDIA LABORATORIES PVT.LTD. |
05/01/2026 |
Valid |
| VIASURE Aspergillus differentiation Real Time PCR Detection Kit (Tube)
82149920149 |
Combined parameters in one product - class II |
II |
CERTEST BIOTEC, S.L. |
29/12/2025 |
Valid |
| VIASURE Aspergillus differentiation Real Time PCR Detection Kit (Tube + EC)
82149920148 |
Combined parameters in one product - class II |
II |
CERTEST BIOTEC, S.L. |
29/12/2025 |
Valid |
| : VIASURE Aspergillus differentiation Real Time PCR Detection Kit com Controle de Extração
82149920147 |
Combined parameters in one product - class II |
II |
CERTEST BIOTEC, S.L. |
29/12/2025 |
Valid |
| VIASURE Aspergillus differentiation Real Time PCR Detection Kit (Strip)
82149920146 |
Combined parameters in one product - class II |
II |
CERTEST BIOTEC, S.L. |
29/12/2025 |
Valid |
| BacScreen OM REAL-TIME PCR Detection Kit
82149920145 |
Combined parameters in one product - class III |
III |
DNA-TECHNOLOGY, RESEARCH & PRODUCTION |
29/12/2025 |
Until 29/12/2035 |
| HTLV Antibodies Diagnostic ELISA Kit
82149920144 |
Human T-lymphotropic virus 1 and 2 (HTLV-1/HTLV-2) antibody |
IV |
BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO., LTD |
24/11/2025 |
Until 24/11/2035 |
| Androflor ® Screen REAL-TIME PCR Detection Kit package A
82149920143 |
Combined parameters in one product - class III |
III |
DNA-TECHNOLOGY, RESEARCH & PRODUCTION |
10/11/2025 |
Until 10/11/2035 |
| Androflor ® Screen REAL-TIME PCR Detection Kit
82149920142 |
Combined parameters in one product - class III |
III |
DNA-TECHNOLOGY, RESEARCH & PRODUCTION |
10/11/2025 |
Until 10/11/2035 |
| Artron Dengue IgG/IgM & NS1 Test
82149920141 |
Dengue |
III |
ARTRON LABORATORIES INC. |
03/11/2025 |
Until 03/11/2035 |
| HiPurA® Paraffin-Embedded Tissue DNA Purification Kit
82149920140 |
Buffers, diluents and other solutions for laboratory analysis |
I |
HIMEDIA LABORATORIES PVT.LTD. |
03/11/2025 |
Valid |
| VIASURE Monkeypox virus Real Time PCR Detection Kit
82149920139 |
Orthopoxvirus |
III |
CERTEST BIOTEC, S.L. |
20/10/2025 |
Until 20/10/2035 |
| PREP-L
82149920138 |
Buffers, diluents and other solutions for laboratory analysis |
I |
DNA-TECHNOLOGY, RESEARCH & PRODUCTION |
13/10/2025 |
Valid |
| Diagnostic Kit for T Cell Infected with Mycobacterium Tuberculose (TB-IGRA)
82149920137 |
Mycobacterium |
III |
BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO., LTD |
22/09/2025 |
Until 22/09/2035 |
| Artron Dengue NS1 Antigen Test
82149920136 |
Dengue |
III |
ARTRON LABORATORIES INC. |
15/09/2025 |
Until 15/09/2035 |
| DTspin
82149920135 |
Sample preparation and processing instrument - pre-analytical phase |
I |
DNA-TECHNOLOGY, RESEARCH & PRODUCTION |
08/09/2025 |
Valid |
| HiPurA® Pre- filled Cartridges for Paraffin-Embedded Tissue Nucleic Acid Purification
82149920134 |
Buffers, diluents and other solutions for laboratory analysis |
I |
HIMEDIA LABORATORIES PVT.LTD. |
01/09/2025 |
Valid |
| HiPurA® Pre-filled Cartridges for Blood DNA Extraction
82149920133 |
Buffers, diluents and other solutions for laboratory analysis |
I |
HIMEDIA LABORATORIES PVT.LTD. |
01/09/2025 |
Valid |
| HiPurA® Pre- filled Plates for Blood DNA Extraction
82149920132 |
Buffers, diluents and other solutions for laboratory analysis |
I |
HIMEDIA LABORATORIES PVT.LTD. |
01/09/2025 |
Valid |