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EUDAMED Device Search

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

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Active filter:Manufacturer SRN:CR-MF-000008155

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Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026385
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-315
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026392
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-340
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026408
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-360
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026415
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-380
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026422
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-405
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026439
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-455
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026446
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-470
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026453
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSF-500
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026576
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSF-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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026583
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSF-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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026590
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSF-300Z
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026606
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSF-315Z
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026613
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSF-340Z
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026620
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSF-360Z
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026637
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSF-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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026644
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSF-405Z
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026651
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSF-455Z
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026668
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSF-470Z
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026675
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSF-500Z
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 20:07
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161026682
Basic UDI-DI
7445161Ergo2DiamZenTempZS
Reference
DSF-240T
EMDN
X020102
EMDN description
PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE TOTALLY INTRODUCED INTO THE HUMAN BODY THROUGH SURGICALLY INVASIVE MEANS FOR THE PURPOSE OF MODIFYING THE ANATOMY OF BODY PARTS WITH THE EXCEPTION OF TATTOOING PRODUCTS AND PIERCINGS – NON RESORBABLE
First on market country
-
Safety summary (SSCP/SSP)
SSCP-001003 · Rev. 2
Authorised representative
Emergo Europe B.V.
Last updated
15.07.2026 20:07