| Product | EU MDR Class | EU MDD Class* |
|---|---|---|
| AeroStat cholangiography catheter | IIa | |
| Alexis protectors and systems | IIa | |
| Scope warmer bottle and base | I non-sterile | |
| Scope warmer seal | I sterile | |
| Epix dissectors | IIb | |
| Epix graspers | IIa | |
| Epix scissors | IIb | |
| Epix universal clip applier | IIb | |
| Epix suction-irrigation system | IIb | |
| Epix electrosugical probes | IIb | |
| GelPOINT platform | IIa | |
| GelPOINT Mini platform | IIa | |
| GelPOINT Path platform | IIa | |
| GelPOINT V-Path platform | IIa | |
| GelPort system | IIa | |
| Insufflation needles | IIa | |
| Inzii retrieval systems | IIa | |
| Kii access systems | IIa | |
| Stealth clips and clamps | IIa | |
| Voyant devices | IIb |
*In March 2023, the EC approved an extension of the Article 120 on transitional provisions in the MDR. This extension allows, under certain criteria, for devices with expired MDD CE certificates to be considered valid and remain on the market until 2027 or 2028, depending on the risk class of the device. The Applied Medical devices adhere to the transitional provisions and their certificates remain valid while they undergo active MDR transition.
