Public EUDAMED Search

EUDAMED Device Search

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

Last updated

24.09.2026 21:51

Sync status

Successful

Device

3624605

Actor

47892

Certificate

3409

Active filter:EMDN:P060101

1000+ device results listed.

Page 35 / 50

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005076
Basic UDI-DI
7445161VelvetPlus62
Reference
RVD-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
07445161005083
Basic UDI-DI
7445161VelvetPlus62
Reference
RVD-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
07445161005090
Basic UDI-DI
7445161VelvetPlus62
Reference
RVD-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
07445161005106
Basic UDI-DI
7445161VelvetPlus62
Reference
RVD-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
07445161005113
Basic UDI-DI
7445161VelvetPlus62
Reference
RVD-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
07445161005120
Basic UDI-DI
7445161VelvetPlus62
Reference
RVD-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
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005137
Basic UDI-DI
7445161VelvetPlus62
Reference
RVD-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
07445161005144
Basic UDI-DI
7445161VelvetPlus62
Reference
RVD-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
07445161005151
Basic UDI-DI
7445161VelvetPlus62
Reference
RVD-425+
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
07445161005168
Basic UDI-DI
7445161VelvetPlus62
Reference
RVD-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
07445161005175
Basic UDI-DI
7445161VelvetPlus62
Reference
RVD-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
07445161005182
Basic UDI-DI
7445161VelvetPlus62
Reference
RVD-575+
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
07445161005199
Basic UDI-DI
7445161VelvetPlus62
Reference
RVD-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
07445161005205
Basic UDI-DI
7445161VelvetPlus62
Reference
RVF-145+
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
07445161005212
Basic UDI-DI
7445161VelvetPlus62
Reference
RVF-175+
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
07445161005229
Basic UDI-DI
7445161VelvetPlus62
Reference
RVF-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
07445161005236
Basic UDI-DI
7445161VelvetPlus62
Reference
RVF-220+
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
07445161005243
Basic UDI-DI
7445161VelvetPlus62
Reference
RVF-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
15.07.2026 20:09
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161005250
Basic UDI-DI
7445161VelvetPlus62
Reference
RVF-255+
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
07445161005267
Basic UDI-DI
7445161VelvetPlus62
Reference
RVF-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
15.07.2026 20:09