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Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161017833
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-215
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161017840
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-265
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161017857
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSC-145
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161017864
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSC-175
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161017871
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSC-210
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161017888
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSC-250
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161017895
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSC-290
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020000
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-95Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020017
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-110Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020024
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-130Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020031
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-155Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020048
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-165Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020055
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-175Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020062
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-180Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020079
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-200Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020086
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-220Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020093
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-235Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020109
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-250Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020116
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-260Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020123
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-275Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08