Chalice Medical Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30132673433013267343Chalice Medical Ltd1N2026-01-01Manton Wood Enterprise Park Worksop Nottinghamshire GB S80 2RS

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2538821270328749K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)DTZ2023-11-01
2538821421194498K201642Paragon Adult Maxi PMP Oxygenator with Tubing PackDTZ2020-09-18
2538821015513018K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)DTZ2020-02-28
2538821021525556

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DTZ32023-11-01

PMN#