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Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011190
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVM-290
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
07445161011206
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVM-310
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
07445161011213
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVM-360
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
07445161011220
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVM-400
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
07445161011237
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVM-430
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
07445161011244
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVM-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
07445161011251
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVM-525
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
07445161011268
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVD-135
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
07445161011275
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVD-155
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
07445161011282
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVD-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
07445161011299
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVD-190
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
07445161011305
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVD-205
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
07445161011312
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVD-215
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
07445161011329
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVD-230
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
07445161011336
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVD-245
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
07445161011343
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVD-265
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
07445161011350
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVD-285
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
07445161011367
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVD-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
07445161011374
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVD-320
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
07445161011381
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVD-340
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