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Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161007186
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSC-510+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
07445161007193
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSC-550+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
07445161007209
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSC-590+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
07445161007216
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSC-650+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
07445161007223
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSC-725+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
07445161007230
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSC-825+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
07445161007247
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSC-925+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 2017/745No longer on the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161007254
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSC-1050+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
07445161008084
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSM-140Z
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
07445161008091
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSM-150Z
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
07445161008107
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSM-160Z
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
07445161008114
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSM-170Z
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
07445161008121
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSM-185Z
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
07445161008138
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSM-205Z
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
07445161008145
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSM-220Z
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
07445161008152
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSM-230Z
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
07445161008169
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSM-245Z
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
07445161008176
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSM-260Z
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
07445161008183
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSM-275Z
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
07445161008190
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSM-290Z
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