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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

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Active filter:Certificate number:MDR 798371

320 device results listed.

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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
29.09.2026 22:50
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011183
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVM-275
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
29.09.2026 22:50
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011107
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVM-160
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
29.09.2026 22:50
Motiva Implants

Motiva Implants Ergonomix Round VelvetSurface

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011060
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVM-105
EMDN
P0601010202
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country
Belgium
Safety summary (SSCP/SSP)
SSCP-001004 · Rev. 1
Authorised representative
Emergo Europe B.V.
Last updated
29.09.2026 22:50
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011787
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVC-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
29.09.2026 22:50
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011763
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVC-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
29.09.2026 22:50
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011725
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVC-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
29.09.2026 22:50
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011657
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVF-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
29.09.2026 22:50
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011640
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVF-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
29.09.2026 22:50
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011633
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVF-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
29.09.2026 22:50
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011626
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVF-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
29.09.2026 22:50
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011541
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVF-315
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
29.09.2026 22:50
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011527
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVF-275
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
29.09.2026 22:50
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161011503
Basic UDI-DI
7445161ErgoVelvetM5
Reference
ERVF-235
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
29.09.2026 22:50
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
29.09.2026 22:50
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
29.09.2026 22:50
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
29.09.2026 22:50
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
29.09.2026 22:50
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
29.09.2026 22:50
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
29.09.2026 22:50