| ATF | 06263494000015 | Arya Teb Firouz Co. | Class IIb | |
| Cleanos | 42607291481004 | AC Aircontrols GmbH | Class IIb | |
| DIMI | 07640137442767 | INFOMED SA | Class IIb | |
| Disposable dialysis kit | 06977405670012 | Guangdong Deshang Medical Products Co.,Ltd. | Class I | |
| Dualex Plus Transducer Protector | 04054839076565 | Merck Millipore Ltd | Class IIa | |
| Dualex Transducer Protector | 04053252666612 | Merck Millipore Ltd | Class IIa | |
| Dualex Transducer Protector | 04054839078217 | Merck Millipore Ltd | Class IIa | |
| Dualex Ultra Transducer Protector | 04054839076572 | Merck Millipore Ltd | Class IIa | |
| HF440 | 07640137442156 | INFOMED SA | Class IIb | |
| IN300 | 07640137442743 | INFOMED SA | Class IIb | |
| KIT DIALISI FISTOLA ARTERO VENOSA (FAV) ED ACCESSORI | 08054042880092 | Cam Hospital srl | Class Is | |
| Metallocene Ura Drain Bag | 00848340008863 | Advance Medical Designs, Inc. | Class Is | |
| Metallocene Ura Drain Bag | 00848340008931 | Advance Medical Designs, Inc. | Class Is | |
| Metallocene Uro Drain Bag | 00848340008917 | Advance Medical Designs, Inc. | Class Is | |
| Metallocene Uro Drain Bag | 00848340009488 | Advance Medical Designs, Inc. | Class Is | |
| Metallocene Uro Drain Bag | 00848340009501 | Advance Medical Designs, Inc. | Class Is | |
| Metallocene Uro Drain Bag w/ Flap | 00848340002144 | Advance Medical Designs, Inc. | Class Is | |
| Metallocene Uro Drain Bag w/ Flap | 00848340002151 | Advance Medical Designs, Inc. | Class Is | |
| Metallocene Uro Drain Bag w/ Flap | 00848340002168 | Advance Medical Designs, Inc. | Class Is | |
| Metallocene Uro Drain Bag w/ Flap | 00848340008573 | Advance Medical Designs, Inc. | Class Is | |
| Metallocene Uro Drain Bag w/ Flap | 00848340008887 | Advance Medical Designs, Inc. | Class Is | |
| Metallocene Uro Drn Bag | 00848340002113 | Advance Medical Designs, Inc. | Class Is | |
| Metallocene Uro Orn Bag UB Flap | 00848340002120 | Advance Medical Designs, Inc. | Class Is | |
| Metallocene Uro Orn Bag w/ UB Flap | 00848340008856 | Advance Medical Designs, Inc. | Class Is | |
| NxStage Fluid Detection System | 00842289103702 | NxStage Medical, Inc. | Class IIb | |
| NxStage System One Cycler Base & Fluid Detection Sensor | 00842289103689 | NxStage Medical, Inc. | Class IIb | |
| Polyethylene Easy Catcher | 00848340010743 | Advance Medical Designs, Inc. | Class Is | |
| Polyethylene Easy Catcher | 00848340010750 | Advance Medical Designs, Inc. | Class Is | |
| Polyethylene Easy Catcher | 00848340010767 | Advance Medical Designs, Inc. | Class Is | |
| Polyethylene Easy Catcher | 00848340010774 | Advance Medical Designs, Inc. | Class Is | |
| Polyethylene Ura Drain Bag | 00848340012952 | Advance Medical Designs, Inc. | Class Is | |
| Prism0cal | 07332414091262 | Bieffe Medital S.p.A. | Class IIb | |
| Prism0cal | 07332414104535 | Bieffe Medital S.p.A. | Class IIb | |
| Prism0cal B22 | 07332414111120 | Bieffe Medital S.p.A. | Class IIb | |
| Prism0cal B22 | 07332414111137 | Bieffe Medital S.p.A. | Class IIb | |
| Prism0cal B22 | 07332414121075 | Bieffe Medital S.p.A. | Class IIb | |
| Prism0cal B22 | 07332414123154 | Bieffe Medital S.p.A. | Class IIb | |
| Prism0cal B22 | 07332414126308 | Bieffe Medital S.p.A. | Class IIb | |
| Prismocitrate | 07332414120283 | Bieffe Medital S.p.A. | Class IIb | |
| Prismocitrate | 07332414120290 | Bieffe Medital S.p.A. | Class IIb | |
| Prismocitrate | 07332414120306 | Bieffe Medital S.p.A. | Class IIb | |
| Prismocitrate | 07332414123147 | Bieffe Medital S.p.A. | Class IIb | |
| Prismocitrate | 07332414125028 | Bieffe Medital S.p.A. | Class IIb | |
| Prismocitrate | 07332414126896 | Bieffe Medital S.p.A. | Class IIb | |
| Redsense Alarm system EU charger | 07350078030113 | Redsense Medical AB | Class I | |
| Redsense Alarm unit with FOE, IFU, charger EU | 07350078030021 | Redsense Medical AB | Class I | |
| Redsense Catheter Sensor Patch | 07350078030342 | Redsense Medical AB | Class I | |
| Redsense Clamp System | 07350078030373 | Redsense Medical AB | Class I | |
| Redsense FOE | 07350078030090 | Redsense Medical AB | Class I | |
| Redsense FOE | 07350078030441 | Redsense Medical AB | Class I | |