| FLEX FORM LINE - HS NEPHRO CATHETER | 08058983743584 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO CATHETER | 08058983743591 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO CATHETER | 08058983743621 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08033055147743 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08033055147750 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08033055147880 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08033055147897 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08033055147903 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08033055149112 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08033055149457 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08033055149464 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08033055149471 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08033055149488 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08033055149495 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08058983742075 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08058983742082 | H.S. Hospital Service S.p.A. | Class IIa | |
| FLEX FORM LINE - HS NEPHRO MALECOT | 08058983742099 | H.S. Hospital Service S.p.A. | Class IIa | |
| Foley Balloon Catheter (Cathtec) | +G4011733FL0820FR0/$$331083126CD0410 | Disposafe Health & Lifecare Limited | Class IIa | |
| Foley Balloon Catheter (Cathtec) | +G4011733FL0822FR0/$$331083126CD0411+ | Disposafe Health & Lifecare Limited | Class IIa | |
| Foley Balloon Catheter (Cathtec) | +G4011733FL0824FR0/$$331083126CD04121 | Disposafe Health & Lifecare Limited | Class IIa | |
| Kolibri | 03600040953822 | Coloplast A/S | Class IIb | |
| Kolibri | 03600040953853 | Coloplast A/S | Class IIb | |
| Kolibri | 03600040953884 | Coloplast A/S | Class IIb | |
| Kolibri | 03600040953945 | Coloplast A/S | Class IIb | |
| Kolibri | 03600040954003 | Coloplast A/S | Class IIb | |
| Kolibri | 03600040954034 | Coloplast A/S | Class IIb | |
| Kolibri | 03600040954065 | Coloplast A/S | Class IIb | |
| Kolibri | 03600040954096 | Coloplast A/S | Class IIb | |
| Kolibri | 03600040975671 | Coloplast A/S | Class IIb | |
| Kolibri | 03600040975701 | Coloplast A/S | Class IIb | |
| Kolibri | 03600040975763 | Coloplast A/S | Class IIb | |
| Malecot Catheter | 08905080009344 | Blue Neem Medical Devices Private Limited | Class IIa | |
| Malecot Catheter | 08905080059646 | Blue Neem Medical Devices Private Limited | Class IIa | |
| NEPHRO-CATH | 10817640020148 | UreSil, LLC | Class III | |
| NEPHRO-CATH | 10817640020155 | UreSil, LLC | Class III | |
| NEPHRO-CATH | 10817640021602 | UreSil, LLC | Class III | |
| NEPHRO-CATH | 10817640021619 | UreSil, LLC | Class III | |
| NephroMax™ | 08714729012641 | Boston Scientific Corporation | Class IIa | |
| NephroMax™ | 08714729826484 | Boston Scientific Corporation | Class IIa | |
| NephroMax™ | 08714729826491 | Boston Scientific Corporation | Class IIa | |
| NephroMax™ | 08714729826507 | Boston Scientific Corporation | Class IIa | |
| Nephrostomy Catheters | 08809157670621 | Yushin Medical Co., Ltd. | Class IIb | |
| Nephrostomy Catheters | 08809157670638 | Yushin Medical Co., Ltd. | Class IIb | |
| Nephrostomy Catheters | 08809157670645 | Yushin Medical Co., Ltd. | Class IIb | |
| Nephrostomy Catheters | 08809157670652 | Yushin Medical Co., Ltd. | Class IIb | |
| Nephrostomy Catheters | 08809157670669 | Yushin Medical Co., Ltd. | Class IIb | |
| Nephrostomy Catheters | 08809157670676 | Yushin Medical Co., Ltd. | Class IIb | |
| Nephrostomy Catheters | 08809157670683 | Yushin Medical Co., Ltd. | Class IIb | |
| Nephrostomy Catheters | 08809157670690 | Yushin Medical Co., Ltd. | Class IIb | |
| Nephrostomy Catheters | 08809157670706 | Yushin Medical Co., Ltd. | Class IIb | |