| Grael v2 | 09342451001269 | Compumedics Limited | Class IIa | |
| Grael v2 - EU | 09342451007759 | Compumedics Limited | Class IIa | |
| JFD5001 | 04250413404988 | SOMNOmedics AG | Class IIa | |
| JFD7001HD | 04250413410798 | SOMNOmedics AG | Class IIa | |
| MiniScreen Pro Patient Recorder | 04251978600402 | Dr. Fenyves und Gut Deutschland GmbH | Class IIa | |
| Nox A1S SAS kit | 15694311112082 | Nox Medical | Class IIa | |
| Nox C1 Access Point | 15694311110590 | Nox Medical | Class IIa | |
| Nox C1 Kit | 15694311111146 | Nox Medical | Class IIa | |
| Nox T3s System, EU | 15694311111450 | Nox Medical | Class IIa | |
| Onera STS I | 08720256698012 | Onera B.V. | Class IIa | |
| Onera STS I | 08720256698029 | Onera B.V. | Class IIa | |
| Onera STS I | 08720256698036 | Onera B.V. | Class IIa | |
| Onera STS I | 08720256698043 | Onera B.V. | Class IIa | |
| Onera STS I | 08720256698050 | Onera B.V. | Class IIa | |
| Onera STS I | 08720256698067 | Onera B.V. | Class IIa | |
| Onera STS I | 08720256698074 | Onera B.V. | Class IIa | |
| Onera STS I | 08720256698098 | Onera B.V. | Class IIa | |
| Onera STS I | 08720256698111 | Onera B.V. | Class IIa | |
| Onera STS I | 08720256698135 | Onera B.V. | Class IIa | |
| Onera STS I | 08720256698159 | Onera B.V. | Class IIa | |
| Onera STS I | 08720256698173 | Onera B.V. | Class IIa | |
| Onera STS I | 08720256698197 | Onera B.V. | Class IIa | |
| ONERA STS I | 08720256698005 | Onera B.V. | Class IIa | |
| Polígrafo Screen&Go | 08436035524037 | SIBEL SAU | Class IIa | |
| Polígrafo Sleep&Go A | 08436035524044 | SIBEL SAU | Class IIa | |
| Polígrafo Sleep&Go B | 08436035524051 | SIBEL SAU | Class IIa | |
| Polypro Polysomnograph | 06948538361122 | BMC Medical Co., Ltd. | Class IIa | |
| Polypro Polysomnograph | 06948538361139 | BMC Medical Co., Ltd. | Class IIa | |
| Polypro Portable Sleep Diagnostic System | 06948538361108 | BMC Medical Co., Ltd. | Class IIa | |
| Polypro Portable Sleep Diagnostic System | 06948538361115 | BMC Medical Co., Ltd. | Class IIa | |
| PolyWatch Portable Sleep Diagnostic System | 06948538361016 | BMC Medical Co., Ltd. | Class IIa | |
| PolyWatch Sleep Screener | 06948538361009 | BMC Medical Co., Ltd. | Class IIa | |
| Portable Sleep Diagnostic System | 06948538361153 | BMC Medical Co., Ltd. | Class IIa | |
| Portable Sleep Diagnostic System | 06948538361160 | BMC Medical Co., Ltd. | Class IIa | |
| Recert, Alice NightOne Intl | 00606959409330 | Respironics Inc. | Class IIa | |
| Recert, Alice NightOne Intl Wireless | 00606959409323 | Respironics Inc. | Class IIa | |
| Reusable Jumper Linker Cable | 00382830058070 | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK) | Class I | |
| Reusable Shielded 3-in-1 Monopolar Extension Cable | 00382830000277 | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK) | Class I | |
| Reusable Stackable Jumper Linker Cable | 00382830000222 | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK) | Class I | |
| Reusable Touchproof Interconnection Cable | 00382830058087 | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK) | Class I | |
| Single Use Universal RIP Kit - Abdomen | 00382830047456 | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK) | Class IIa | |
| Single Use Universal RIP Kit – Complete | 00382830047470 | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK) | Class IIa | |
| Single Use Universal RIP Kit - Thorax | 00382830047463 | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK) | Class IIa | |
| Sistema Screen&Go | 08436035524211 | SIBEL SAU | Class IIa | |
| Sistema Sleep&Go A | 08436035524228 | SIBEL SAU | Class IIa | |
| Sistema Sleep&Go B | 08436035524235 | SIBEL SAU | Class IIa | |
| Sleep Adagio PG | 04250413405749 | SOMNOmedics AG | Class IIa | |
| Sleep Adagio® PG | 04250413403837 | SOMNOmedics AG | Class IIa | |
| Sleep Adagio® PG pro | 04250413403844 | SOMNOmedics AG | Class IIa | |
| Sleep Adagio Pro without PLM | 04250413406876 | SOMNOmedics AG | Class IIa | |