Manufacturer's Devices - TransMedics Inc.

Address:




200 Minuteman Road Suite 302



Andover

Massachusetts 01810

United States


Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:

Compass House Vision Park Histon c/o Cr360 – UL International



Cambridge

CB24 9BZ

England United Kingdom




Code/Term Type
Rechargeable battery packRechargeable battery packClass I
Data storage cardData storage cardClass I
Gas/fluid regulator gasketGas/fluid regulator gasketClass I
Donor-organ preservation/transport system gas refillable cylinderDonor-organ preservation/transport system gas refillable cylinderClass I
Donor-organ preservation/transport system gas cylinder regulatorDonor-organ preservation/transport system gas cylinder regulatorClass I
Electrical mains power cableElectrical mains power cableClass I
Donor-organ preservation solutionDonor-organ preservation solution Conformity Assessment Certificate ExpiredClass IIa
Donor-organ preservation/transport perfusion initiation/termination setDonor-organ preservation/transport perfusion initiation/termination set Conformity Assessment Certificate ExpiredClass IIa
Donor-organ preservation/transport perfusion set connection kitDonor-organ preservation/transport perfusion set connection kit Conformity Assessment Certificate ExpiredClass IIa
Donor-organ preservation/transport perfusion set vessel tie toolDonor-organ preservation/transport perfusion set vessel tie tool Conformity Assessment Certificate ExpiredClass IIa
Liver donor-organ preservation/transport perfusion setLiver donor-organ preservation/transport perfusion set Conformity Assessment Certificate ExpiredClass IIa
Lung donor-organ preservation/transport perfusion setLung donor-organ preservation/transport perfusion set Conformity Assessment Certificate ExpiredClass IIa
Lung donor-organ preservation/transport systemLung donor-organ preservation/transport system Conformity Assessment Certificate ExpiredClass IIa
Exsanguination setExsanguination set Conformity Assessment Certificate ExpiredClass IIa
Liver donor-organ preservation/transport systemLiver donor-organ preservation/transport system Conformity Assessment Certificate ExpiredClass IIa
Heart donor-organ preservation/transport systemHeart donor-organ preservation/transport system Conformity Assessment Certificate ExpiredClass IIa
Heart donor-organ preservation/transport perfusion setHeart donor-organ preservation/transport perfusion set Conformity Assessment Certificate ExpiredClass IIa