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EUDAMED Device Search

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

Last updated

23.09.2026 08:13

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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
07445161026897
Basic UDI-DI
7445161Ergo2DiamondDH
Reference
DSC-610
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
07445161027016
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSC-270Z
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
07445161027023
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSC-330Z
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
07445161027030
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSC-355Z
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
07445161027047
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSC-370Z
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
07445161027054
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSC-395Z
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
07445161027061
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSC-425Z
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
07445161027078
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSC-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
07445161027085
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSC-485Z
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
07445161027092
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSC-530Z
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
07445161027108
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSC-565Z
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
07445161027115
Basic UDI-DI
7445161Ergo2ZenBQ
Reference
DSC-610Z
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
07445161027122
Basic UDI-DI
7445161Ergo2DiamZenTempZS
Reference
DSC-270T
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
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161027139
Basic UDI-DI
7445161Ergo2DiamZenTempZS
Reference
DSC-330T
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
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161027146
Basic UDI-DI
7445161Ergo2DiamZenTempZS
Reference
DSC-355T
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
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161027153
Basic UDI-DI
7445161Ergo2DiamZenTempZS
Reference
DSC-370T
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
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161027160
Basic UDI-DI
7445161Ergo2DiamZenTempZS
Reference
DSC-395T
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
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161027177
Basic UDI-DI
7445161Ergo2DiamZenTempZS
Reference
DSC-425T
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
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161027184
Basic UDI-DI
7445161Ergo2DiamZenTempZS
Reference
DSC-455T
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
Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
Manufacturer
Establishment Labs
Manufacturer SRN
CR-MF-000008155
UDI-DI
07445161027191
Basic UDI-DI
7445161Ergo2DiamZenTempZS
Reference
DSC-485T
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