Public EUDAMED Search

EUDAMED Device Search

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

Last updated

24.09.2026 21:13

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Certificate

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Active filter:Certificate number:MDR 768275

621 device results listed.

Page 12 / 32

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161017727
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSM-140
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
07445161017734
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSM-165
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
07445161017741
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSM-190
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
07445161017758
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSD-120
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
07445161017765
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSD-140
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
07445161017772
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSD-170
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
07445161017789
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSD-195
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
07445161017796
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSD-220
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
07445161017802
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-135
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
07445161017819
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-160
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
07445161017826
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-190
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
07445161017833
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-215
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
07445161017840
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-265
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
07445161017857
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSC-145
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
07445161017864
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSC-175
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
07445161017871
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSC-210
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
07445161017888
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSC-250
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
07445161017895
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSC-290
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
07445161020000
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-95Z
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
07445161020017
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
E2SM-110Z
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