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Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006790
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-360+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006806
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-380+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006813
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-425+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006820
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-475+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006837
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-525+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006844
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-575+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006851
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-625+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006868
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-145+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006875
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-175+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006882
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-205+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006899
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-220+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006905
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-235+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006912
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-255+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006929
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-275+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006936
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-295+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006943
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-315+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006950
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-335+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006967
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-355+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006974
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-375+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006981
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-400+Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-00100 · Rev. 8
Authorised representative
Emergo Europe B.V.
Last updated
13.07.2026 08:57