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Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005373
Basic UDI-DI
7445161VelvetPlus62
Reference
RVF-625+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005380
Basic UDI-DI
7445161VelvetPlus62
Reference
RVF-700+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005397
Basic UDI-DI
7445161VelvetPlus62
Reference
RVF-775+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005403
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-180+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005410
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-210+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005427
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-240+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005434
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-260+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005441
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-280+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005458
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-300+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005465
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-325+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005472
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-350+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005489
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-380+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005496
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-410+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005502
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-440+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005519
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-475+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005526
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-510+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005533
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-550+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005540
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-590+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005557
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-650+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005564
Basic UDI-DI
7445161VelvetPlus62
Reference
RVC-725+
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:09