Public EUDAMED Search

EUDAMED Device Search

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

Last updated

31.08.2026 14:52

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Successful

Device

3108040

Actor

47631

Certificate

3281

Active filter:Certificate number:MDR 768275

621 device results listed.

Page 15 / 32

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020420
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-135Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020437
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-155Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020444
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-190Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020451
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-215Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020468
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-240Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020475
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-250Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020482
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-275Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020499
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-290Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020505
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-320Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020512
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-330Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020529
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-355Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020536
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-380Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020543
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-400Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020550
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-430Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020567
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-450Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020574
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-475Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020581
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-535Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020598
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-595Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020604
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-670Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161020611
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SF-750Z
EMDN
P0601010201
EMDN description
BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:08