08800111725661 88001117IPCA01FA05VX STANDARD™ F HbA1c SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C UNKNOWN Piyasada 10A1C20B 2026-07-05T13:21:30.259Z 08800111725678 88001117IPCA02FA05WA SDB HbA1c Control SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C UNKNOWN Piyasada 10A1CC20 2026-07-05T13:21:30.212Z 08800111723117 88001117IPBA01MA05WV STANDARD™ M10 C. difficile BT STANDARD™ M10 C. difficile BT SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf B IVDR 2017/746 W0105011804 C.DIFFICILE BY NA REAGENTS Piyasada 11CDC20A Italy 2026-07-03T17:32:53.028Z 08800111722929 88001117IPCA01MA19XT STANDARD™ M10 MTB-RIF/INH STANDARD™ M10 MTB-RIF/INH SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C IVDR 2017/746 W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS Piyasada M10-MTB-02/11MTB30A Italy 2026-07-03T17:32:52.230Z 08800111722691 88001117IPAA05IA01WJ STANDARD™ i pre-Trigger STANDARD™ i pre-Trigger SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES Piyasada 16PTR10 Italy 2026-07-03T17:32:48.229Z 08800111722684 88001117IPAA06IA01WV STANDARD™ i Trigger STANDARD™ i Trigger SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES Piyasada 16TR10 Italy 2026-07-03T17:32:47.423Z 08800111722677 88001117IPAA07IA01X8 STANDARD™ i Wash buffer STANDARD™ i Wash buffer SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) Piyasada 16WB10 Italy 2026-07-03T17:32:46.724Z 08800111722035 88001117IPBA01IA12VW STANDARD™ i TSH STANDARD™ i TSH SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf B IVDR 2017/746 W01020410 THYROID STIMULATING HORMONE Piyasada 16TSH10D Italy 2026-07-03T17:32:45.039Z 08800111724831 88001117IAAA01PA14L7 STANDARD™ LMS (Lipid Management Software) STANDARD™ LMS (Lipid Management Software) SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0201010182 CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES Piyasada 02LMS10 Romania 2026-07-03T17:30:35.292Z 08800111724824 88001117IAAA01PA15L9 STANDARD™ DMS (Diabetes Management Software) STANDARD™ DMS (Diabetes Management Software) SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0201010182 CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES Piyasada 01DMS10 Romania 2026-07-03T17:30:33.699Z 08800111724817 88001117IAAA02PA15LL Pic Diabetes Management Pic Diabetes Management SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0201010182 CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES Piyasada 99DMS30 Italy 2026-07-03T17:30:32.909Z 08800111724800 88001117IAAA01PA16LB GlucoNavii® App GlucoNavii® App SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0201010182 CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES Piyasada 01APP10 Romania 2026-07-03T17:30:31.305Z 08800111722660 88001117IPAA04IA01W7 STANDARD™ i Cleanser STANDARD™ i Cleanser SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES Piyasada 16CL10 Italy 2026-07-03T17:30:28.897Z 08800111720260 88001117IPAA01IA02V8 STANDARD™ i2000 STANDARD™ i2000 SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) Piyasada 16IA200 Italy 2026-07-03T17:30:27.297Z 08800111720253 88001117IPAA01IA01V6 STANDARD™ i1000 STANDARD™ i1000 SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) Piyasada 16IA100 Italy 2026-07-03T17:30:26.492Z 08800111719219 88001117IPAA01MA12W7 STANDARD™ M10 STI Sample Pretreatment Kit STANDARD™ M10 STI Sample Pretreatment Kit SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES Piyasada M10-STIP-01 Italy 2026-07-03T17:30:24.896Z 08800111718557 88001117IPAA01MA13W9 STANDARD™ M10 Stool Pretreatment kit STANDARD™ M10 Stool Pretreatment Kit SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0105900201 BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC Piyasada 11PRT20A Italy 2026-07-03T17:30:21.706Z 08800111718540 88001117IPAA01MA11W5 STANDARD™ M10 Sputum Pretreatment Kit STANDARD™ M10 Sputum Pretreatment Kit SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0105900201 BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC Piyasada M10-SPTP-01/11PRT10A Italy 2026-07-03T17:30:20.083Z 08800111711350 88001117IPAA01MA02W4 STANDARD™ M10 Calibration Kit STANDARD™ M10 Calibration Kit SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0101050302 CALIBRATORS SINGLE COMPONENT (CC) Piyasada M10-CAL-01/11CAL10H Italy 2026-07-03T17:30:19.289Z 08800111711213 88001117IPAA01FA29V7 STANDARD™ F Calibration Kit STANDARD™ F Calibration Kit SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf A IVDR 2017/746 W0101050302 CALIBRATORS SINGLE COMPONENT (CC) Piyasada 10CAL10 Italy 2026-07-03T17:30:17.682Z