Public EUDAMED Search

EUDAMED Device Search

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

Last updated

15.10.2026 00:58

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Device

4165125

Actor

48064

Certificate

3479

Active filter:Certificate number:MDR 745219

318 device results listed.

Page 1 / 16

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008701
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-280Z
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
29.09.2026 22:54
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008725
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-325Z
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
29.09.2026 22:54
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008695
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-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
29.09.2026 22:54
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008688
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-240Z
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
29.09.2026 22:54
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008671
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-210Z
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
29.09.2026 22:54
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008459
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-625Z
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
29.09.2026 22:54
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008442
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-575Z
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
29.09.2026 22:54
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008435
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-525Z
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
29.09.2026 22:52
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008428
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-475Z
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
29.09.2026 22:52
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008411
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-425Z
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
29.09.2026 22:52
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008404
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-380Z
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
29.09.2026 22:52
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008398
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-360Z
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
29.09.2026 22:52
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008381
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-340Z
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
29.09.2026 22:52
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008374
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-320Z
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
29.09.2026 22:52
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008367
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-300Z
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
29.09.2026 22:52
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008350
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-285Z
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
29.09.2026 22:52
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008343
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-265Z
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
29.09.2026 22:52
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008336
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-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
29.09.2026 22:52
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008329
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-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
29.09.2026 22:52
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008312
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSD-215Z
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
29.09.2026 22:52