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 02:58

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Device

4166732

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Certificate

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Active filter:Certificate number:MDR 745219

318 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
07445161008831
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-825Z
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
28.09.2026 22:34
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008824
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-725Z
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
28.09.2026 22:34
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008817
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-650Z
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
28.09.2026 22:34
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008794
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-550Z
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
28.09.2026 22:34
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008787
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-510Z
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
28.09.2026 22:34
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008756
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-410Z
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
28.09.2026 22:34
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008763
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-440Z
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
28.09.2026 22:34
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008749
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-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
28.09.2026 22:34
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008732
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-350Z
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
28.09.2026 22:34
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161008718
Basic UDI-DI
7445161ErgoroundZen8Y
Reference
ERSC-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
28.09.2026 22:34
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161007216
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSC-650+Z
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
25.09.2026 22:49
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161007155
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSC-410+Z
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
25.09.2026 22:49
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161007100
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSC-280+Z
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
25.09.2026 22:49
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161007094
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSC-260+Z
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
25.09.2026 22:49
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161007056
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-775+Z
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
25.09.2026 22:49
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161007032
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-625+Z
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
25.09.2026 22:49
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161007018
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-500+Z
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
25.09.2026 22:49
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161007001
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-450+Z
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
25.09.2026 22:49
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006998
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-425+Z
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
25.09.2026 22:49
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161006974
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-375+Z
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
25.09.2026 22:49