Manufacturer's Devices - Establishment Labs S.A.
Address:
Coyol Free Zone & Business Park Building 4th Street Building B15
Alajuela
Alajuela 20113
Costa Rica
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 |
| Tissue expander injection port locator | Tissue expander injection port locator | Class I
|
| Silicone gel-filled breast implant smooth-surface | Silicone gel-filled breast implant smooth-surface Conformity Assessment Certificate Expired | Class III
|
| Silicone gel-filled breast implant textured-surface | Silicone gel-filled breast implant textured-surface Conformity Assessment Certificate Expired | Class III
|
| Skin-port tissue expander | Skin-port tissue expander Conformity Assessment Certificate Expired | Class III
|
| Invasive breast implant sizer fixed single-use | Invasive breast implant sizer fixed single-use Conformity Assessment Certificate Expired | Class IIa
|
| Invasive breast implant sizer fixed single-use | Invasive breast implant sizer fixed single-use | Class IIa
|
| Invasive breast implant sizer fixed single-use | Silicone gel-filled breast implant textured-surface | Class III
|
| Invasive breast implant sizer fixed single-use | Silicone gel-filled breast implant smooth-surface | Class III
|
| Invasive breast implant sizer fixed single-use | Skin-port tissue expander | Class III
|
| Invasive breast implant sizer fixed single-use | Skin-port tissue expander | Class I
|