| Allplex™ Genital Ulcer Assay
80102512183 |
Combined parameters in one product - class IV |
IV |
SEEGENE INC. |
18/03/2019 |
Until 18/03/2029 |
| AnyplexTM II Thrombosis SNP Panel Assay
80102512182 |
Combined parameters in one product - class III |
III |
SEEGENE INC. |
18/03/2019 |
Until 18/03/2029 |
| Anyplex™ II HPV HR Detection
80102512181 |
Human papillomavirus (HPV) |
III |
SEEGENE INC. |
18/03/2019 |
Until 18/03/2029 |
| Kit Instrumental HPS & DSS
80102512180 |
Instrument kit |
I |
PARADIGM SPINE GMBH |
11/03/2019 |
Valid |
| Nit-Occlud ASD-R
80102512179 |
Septal occluder |
IV |
PFM S.R.L. |
06/03/2019 |
Until 06/03/2029 |
| Sistema de Enxerto de Stent AUI Ankuraᵀ.ᴹ.
80102512178 |
Endoprosthesis (vascular stent graft) |
IV |
LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. |
06/03/2019 |
Until 06/03/2029 |
| Debrisoft® Pad
80102512177 |
Debrider |
II |
LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO. KG. |
06/03/2019 |
Valid |
| DISPOSITIVOS DE FUSÃO INTERVERTEBRAL MECTALIF STAND-ALONE NÃO REVESTIDO
80102512176 |
Spinal fusion cages |
III |
MEDACTA INTERNATIONAL S.A. |
25/02/2019 |
Until 25/02/2029 |
| Sistema de Fluxo Inteligente
80102512175 |
Not yet published |
II |
Not yet published |
25/02/2019 |
Cancelled 02/02/2026 |
| Sistema de Exame Mamário Braster
80102512174 |
Not yet published |
II |
Not yet published |
18/02/2019 |
Cancelled 04/08/2025 |
| SOVA Night Guard
80102512173 |
Oral device for reducing bite force |
I |
AKERVALL TECHNOLOGIES |
18/02/2019 |
Valid |
| Hydrorise
80102512172 |
Not yet published |
I |
Not yet published |
11/02/2019 |
Cancelled 14/02/2024 |
| Hydrorise Implant
80102512171 |
Not yet published |
I |
Not yet published |
11/02/2019 |
Cancelled 14/02/2024 |
| Elite Glass
80102512170 |
Not yet published |
I |
Not yet published |
11/02/2019 |
Cancelled 14/02/2024 |
| Zetalgin
80102512169 |
Not yet published |
I |
Not yet published |
11/02/2019 |
Cancelled 14/02/2024 |
| Elite Cord
80102512168 |
Not yet published |
II |
Not yet published |
28/01/2019 |
Cancelled 14/02/2024 |
| APARELHO DE MICROPIGMENTAÇÃO
80102512167 |
Not yet published |
I |
Not yet published |
28/01/2019 |
Cancelled 03/11/2021 |
| Conector para terapia de infusão estéril FlowArt® sem agulha
80102512166 |
Tubing valves and connectors |
II |
ASSET MEDIKAL TASARIM SAN. VE TIC. AS |
28/01/2019 |
Valid |
| MICROLAB® NIMBUS IVD
80102512165 |
Sample preparation and processing instrument - pre-analytical phase |
I |
HAMILTON COMPANY |
14/01/2019 |
Valid |
| Autoclart® Plus
80102512164 |
Not yet published |
II |
Not yet published |
14/01/2019 |
Cancelled 10/05/2020 |
| Vaporizador Anestésico
80102512163 |
Vaporizer |
III |
PENLON LIMITED |
17/12/2018 |
Until 13/12/2028 |
| Centro de Diagnóstico Móvel EXO (CDM)
80102512162 |
Not yet published |
II |
Not yet published |
17/12/2018 |
Cancelled 03/06/2024 |
| MAGLUMI™ CA 72-4 (CLIA)
80102512161 |
Not yet published |
III |
Not yet published |
10/12/2018 |
Cancelled 07/07/2025 |
| MAGLUMI™ f-PSA (CLIA)
80102512160 |
Not yet published |
III |
Not yet published |
10/12/2018 |
Cancelled 13/10/2025 |
| FAMÍLIA DE INSTRUMENTOS DE PIPETAGEM HAMILTON
80102512159 |
Sample preparation and processing instrument - pre-analytical phase |
I |
HAMILTON COMPANY |
03/12/2018 |
Valid |
| MAGLUMI™ CA 15-3 (CLIA)
80102512158 |
Not yet published |
III |
Not yet published |
03/12/2018 |
Cancelled 07/07/2025 |
| MAGLUMI™ CA 50 (CLIA)
80102512157 |
Not yet published |
III |
Not yet published |
03/12/2018 |
Cancelled 16/09/2024 |
| MAGLUMI™ CEA (CLIA)
80102512156 |
Not yet published |
III |
Not yet published |
03/12/2018 |
Cancelled 07/07/2025 |
| MAGLUMI™ PSA Total (CLIA)
80102512155 |
Not yet published |
III |
Not yet published |
03/12/2018 |
Cancelled 07/07/2025 |
| MAGLUMI IGM DE RUBÉOLA (CLIA)
80102512154 |
Rubella virus |
III |
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. |
03/12/2018 |
Until 03/12/2028 |
| MAGLUMI IGG DE RUBÉOLA (CLIA)
80102512153 |
Rubella virus |
III |
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. |
03/12/2018 |
Until 03/12/2028 |
| SOLERO SISTEMA DE ABLAÇÃO DE TECIDOS POR MICROONDAS
80102512152 |
Surgical ablation device |
III |
ANGIODYNAMICS, INC |
03/12/2018 |
Until 03/12/2028 |
| GSI TympStar Pro
80102512151 |
Audiometer |
II |
DIAGNOSTIC GROUP LLC - DBA GRASON-STADLER |
03/12/2018 |
Valid |
| Colchão NP100
80102512150 |
Hospital mattress |
I |
HILL-ROM SAS |
03/12/2018 |
Valid |
| AllplexTM Bacterial Vaginosis Assay
80102512149 |
Not yet published |
II |
Not yet published |
03/12/2018 |
Cancelled 09/10/2023 |
| AllplexTM Respiratory Panel 2 (AdV / MPV / HEV / PIV)
80102512148 |
Combined parameters in one product - class II |
II |
SEEGENE INC. |
03/12/2018 |
Valid |
| Allplex™ GI-Virus Assay
80102512147 |
Combined parameters in one product - class II |
II |
SEEGENE INC. |
03/12/2018 |
Valid |
| Allplex™ GI-Parasite Assay
80102512146 |
Combined parameters in one product - class II |
II |
SEEGENE INC. |
03/12/2018 |
Valid |
| AllplexTM STI Essential Assay
80102512145 |
Combined parameters in one product - class III |
III |
SEEGENE INC. |
03/12/2018 |
Until 03/12/2028 |
| ELASPUMP
80102512144 |
Infusion device |
II |
MULTIMEDICAL S.R.L. |
12/11/2018 |
Valid |
| Equipo para Medição Urodinâmica
80102512143 |
Administration sets |
II |
LABORIE MEDICAL TECHNOLOGIES, CORP. |
12/11/2018 |
Valid |
| Laborie InjeTAK
80102512142 |
Needles |
II |
LABORIE MEDICAL TECHNOLOGIES, CORP. |
12/11/2018 |
Valid |
| Cateteres para Urodinâmica Laborie
80102512141 |
Catheters |
II |
LABORIE MEDICAL TECHNOLOGIES, CORP. |
12/11/2018 |
Valid |
| AUTO REFRATOR/CERATÔMETRO
80102512140 |
Ophthalmic refractometer |
I |
HUVITZ CO LTD |
05/11/2018 |
Valid |
| Sistema XactTrace™ Reutilizável
80102512139 |
Thoracic respiratory effort sensor |
II |
NATUS MEDICAL INCORPORATED, DBA EXCEL-TECH LTD. |
05/11/2018 |
Valid |
| Sistema XactTrace™ de Uso Único
80102512138 |
Thoracic respiratory effort sensor |
II |
NATUS MEDICAL INCORPORATED, DBA EXCEL-TECH LTD. |
05/11/2018 |
Valid |
| DORNIER ARIES 2
80102512137 |
Shockwave therapy equipment |
II |
DORNIER MEDTECH GMBH |
05/11/2018 |
Valid |
| BÜHLMANN GanglioCombi Light ELISA
80102512136 |
Anti-ganglioside antibodies |
II |
BUHLMANN LABORATORIES AG |
29/10/2018 |
Valid |
| BÜHLMANN GanglioCombi MAG ELISA
80102512135 |
Anti-ganglioside antibodies |
II |
BUHLMANN LABORATORIES AG |
29/10/2018 |
Valid |
| AUTO REFRATOR/CERATÔMETRO
80102512134 |
Ophthalmic refractometer |
II |
HUVITZ CO LTD |
29/10/2018 |
Valid |