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EUDAMED Device Search

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

Last updated

25.09.2026 11:18

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Active filter:Certificate number:MDR 798371

320 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
07445161018700
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-180Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018717
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-210Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018724
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-240Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018731
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-260Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018748
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-280Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018755
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-300Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018762
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-325Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018779
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-350Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018786
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-380Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018793
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-410Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018809
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-440Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018816
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-475Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018823
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-510Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018830
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-550Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018847
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-590Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018854
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-650Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018861
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-725Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018878
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-825Z
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 20:08
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018885
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-925Z
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 20:08
Class IIIMDR 2017/745No longer on the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161018892
Basic UDI-DI
7445161ErgoVelvetZenPE
Reference
ERVC-1050Z
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 20:08