| AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | K241428 | FDA 510(k) | Class II | Active |
| AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | K250727 | FDA 510(k) | Class II | Active |
| Shinetell Digital Pregnancy Test | K241978 | FDA 510(k) | Class II | Active |
| AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | K242540 | FDA 510(k) | Class II | Active |
| Alltest Pregnancy Rapid Combo Test Cassette | K203272 | FDA 510(k) | Class II | Active |
| AllTest Fentanyl Urine Test Cassette | K233417 | FDA 510(k) | Class II | Active |
| AllTest Viral Transport Medium | K242576 | FDA 510(k) | Class I | Active |
| AllTest Fentanyl Rapid Test (Urine) | K231698 | FDA 510(k) | Class II | Active |
| Shinetell PlusTM Digital Early Pregnancy Test | K251053 | FDA 510(k) | Class II | Active |
| Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) | K182738 | FDA 510(k) | Class II | Active |
| Fob | TFO-602 | EUDAMED | IVD General | Active |
| Schnelltest Gesunder Darm | 600401 | EUDAMED | IVD devices for self-testing | Active |
| Multi- Drug Rapid Test | DOA-N144-002B | EUDAMED | Class B | Active |
| Blood Glucose Meter Ⅱ | AGL-400 | EUDAMED | Class A | Active |
| Multi- Drug Rapid Test | DOA-N154-007J | EUDAMED | Class B | Active |
| Uric Acid Meter | AUAR-100ST10 | EUDAMED | Class A | Active |
| Multi- Drug Rapid Test | DOA-N1104-019B | EUDAMED | Class B | Active |
| H. pylori Antigen Rapid Test | IHP-N602B-20 | EUDAMED | Class B | Active |
| Adenovirus Antigen Rapid Test Cassette | IAD-502 | EUDAMED | IVD General | Active |
| Multi- Drug Rapid Test | DOA-N154-045J | EUDAMED | Class B | Active |
| 16-Channel Fluorescence Immunoassay Analyzer | AFR-800 | EUDAMED | Class A | Active |
| Multi- Drug Rapid Test | DOA-N164-027 | EUDAMED | Class B | Active |
| Vaginale Infektionsvorsorge | 600200 | EUDAMED | IVD devices for self-testing | Active |
| Pregnancy (hCG) Enhanced Sensitivity Rapid Test Cassette | FHC-U102H | EUDAMED | IVD devices for self-testing | Active |
| Multi- Drug Rapid Test | DOA-N134-014B | EUDAMED | Class B | Active |
| Multi- Drug Rapid Test | DOA-N164-025B | EUDAMED | Class B | Active |
| Multi- Drug Rapid Test | DOA-N144-002 | EUDAMED | Class B | Active |
| Test ciążowy hCG strumieniowy Szybki test ciążowy hCG o zwiększonej czułości (z moczu) | FHC-U103H | EUDAMED | IVD devices for self-testing | Active |
| Multi- Drug Rapid Test | DOA-N164-016J | EUDAMED | Class B | Active |
| PCT Rapid Test | CPC-N302B-25 | EUDAMED | Class C | Active |
| Multi- Drug Rapid Test | DOA-N164-043B | EUDAMED | Class B | Active |
| Multi- Drug Rapid Test | DOA-N144-017 | EUDAMED | Class B | Active |
| Καζέηα Ηαρείαο Εμέηαζεο Fob | TFO-602H | EUDAMED | IVD devices for self-testing | Active |
| Multi- Drug Rapid Test | DOA-N134-010J | EUDAMED | Class B | Active |
| Multi- Drug Rapid Test | DOA-N164-014B | EUDAMED | Class B | Active |
| Multi- Drug Rapid Test | DOA-N164-013J | EUDAMED | Class B | Active |
| Sperm Concentration Rapid Test Cassette | OSC-902H | EUDAMED | IVD devices for self-testing | Active |
| hCG Pregnancy Enhanced Sensitivity Rapid Test Midstream | FHC-U103H | EUDAMED | IVD devices for self-testing | Active |
| Multi- Drug Rapid Test | DOA-N154-032B | EUDAMED | Class B | Active |
| Multi- Drug Rapid Test | DOA-N164-037B | EUDAMED | Class B | Active |
| Cortisol (COR) Rapid Test (Oral Fluid) | FCOR-803 | EUDAMED | IVD General | Active |
| Multi- Drug Rapid Test | DOA-N174-016B | EUDAMED | Class B | Active |
| Multi- Drug Rapid Test | DOA-N134-022 | EUDAMED | Class B | Active |
| Multi- Drug Rapid Test | DOA-N164-030J | EUDAMED | Class B | Active |
| Cup Reader | ACR-100 | EUDAMED | Class A | Active |
| Multi- Drug Rapid Test | DOA-N164-044 | EUDAMED | Class B | Active |
| H. pylori Antibody Rapid Test | IHP-N402B-40 | EUDAMED | Class B | Active |
| Multi- Drug Rapid Test | DOA-N164-031J | EUDAMED | Class B | Active |
| Gesunder Magen | 600903 | EUDAMED | IVD devices for self-testing | Active |
| Multi- Drug Rapid Test | DOA-N154-015B | EUDAMED | Class B | Active |