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 05:28

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Certificate

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Active filter:Certificate number:MDR 745219

318 device results listed.

Page 7 / 16

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161007049
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-700+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
07445161006929
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-275+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
07445161006905
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-235+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
07445161006882
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSF-205+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
07445161006820
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-475+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
07445161006813
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-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
07445161006790
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-360+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
07445161006783
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-340+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
07445161006721
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-230+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
07445161006714
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-215+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
07445161006707
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-205+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
07445161006691
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-190+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
07445161006684
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSD-180+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
07445161006622
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSM-400+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
07445161006608
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSM-310+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
07445161006585
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSM-275+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
07445161006561
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSM-245+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
07445161006554
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSM-230+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
07445161006530
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSM-205+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
07445161006493
Basic UDI-DI
7445161SilkPlusZen8Z
Reference
RSM-150+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