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MELT IN MOUTH TABLETS

Class IIIMDR 2017/745On the marketAnimal tissuesDirect marking

Manufacturer: SOFAR SWISS SA
Manufacturer SRN: CH-MF-000047475
UDI-DI: 07640158970485
Basic UDI-DI: 764015897GERDOFFSE
Reference: GF-C04L
EMDN: G99
EMDN description: GASTROINTESTINAL DEVICES - OTHER
First on market country: Lithuania
Safety summary (SSCP/SSP): ANTI-REFLUX MELT IN MOUTH TABLET · Rev. 00
Authorised representative: ALFASIGMA S.P.A.
Last updated: 17.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Motiva Implants Ergonomix2 Oval SmoothSilk with ZenT

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161024602
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OM-135T
EMDN: P0601010202
EMDN description: BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country: Belgium
Safety summary (SSCP/SSP): SSCP-001003 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Motiva Implants Ergonomix2 Oval SmoothSilk with Zen

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161024053
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OM-135Z
EMDN: P0601010202
EMDN description: BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country: Belgium
Safety summary (SSCP/SSP): SSCP-001003 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Motiva Implants Ergonomix2 Oval SmoothSilk

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161022950
Basic UDI-DI: 7445161Ergo2OvalWM
Reference: E2OM-135
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: Belgium
Safety summary (SSCP/SSP): SSCP-001003 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Motiva Implants Ergonomix2 SmoothSilk with ZenT

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161022752
Basic UDI-DI: 7445161Ergo2DiamZenTempZS
Reference: DSM-125T
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: Belgium
Safety summary (SSCP/SSP): SSCP-001003 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Motiva Implants Ergonomix2 SmoothSilk with ZenT

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161021915
Basic UDI-DI: 7445161Ergo2ZenTempNR
Reference: E2SM-110T
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: Belgium
Safety summary (SSCP/SSP): SSCP-001003 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Motiva Implants Ergonomix VelvetSurface with Zen

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161018113
Basic UDI-DI: 7445161ErgoVelvetZenPE
Reference: ERVM-125Z
EMDN: P0601010202
EMDN description: BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country: Belgium
Safety summary (SSCP/SSP): SSCP-001004 · Rev. 1
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Motiva Implants Ergonomix2 SmoothSilk

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161017710
Basic UDI-DI: 7445161Ergo2DiamondDH
Reference: DSM-125
EMDN: P0601010201
EMDN description: BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country: Belgium
Safety summary (SSCP/SSP): SSCP-001003 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Silicone Breast Motiva Implants Ergonomix2 SmoothSilk

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161015419
Basic UDI-DI: 7445161Ergo2AX
Reference: E2SM-110
EMDN: P0601010201
EMDN description: BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country: Belgium
Safety summary (SSCP/SSP): SSCP-001003 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Motiva Implants Ergonomix Round VelvetSurface

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161011077
Basic UDI-DI: 7445161ErgoVelvetM5
Reference: ERVM-125
EMDN: P0601010202
EMDN description: BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country: Belgium
Safety summary (SSCP/SSP): SSCP-001004 · Rev. 1
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Motiva Implants Ergonomix Round SmoothSilk/SilkSurface

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161010278
Basic UDI-DI: 7445161ErgoroundR5
Reference: ERSM-125
EMDN: P0601010201
EMDN description: BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country: Belgium
Safety summary (SSCP/SSP): SSCP-00100 · Rev. 8
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

DSM-100Z

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161009296
Basic UDI-DI: 7445161Ergo2ZenBQ
Reference: DSM-125Z
EMDN: P0601010201
EMDN description: BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country: Belgium
Safety summary (SSCP/SSP): SSCP-001003 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

ERSM-105Z

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161008077
Basic UDI-DI: 7445161ErgoroundZen8Y
Reference: ERSM-125Z
EMDN: P0601010201
EMDN description: BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country: Belgium
Safety summary (SSCP/SSP): SSCP-00100 · Rev. 8
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Motiva Implants Round SmoothSilk/SilkSurface Plus with Zen

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161006479
Basic UDI-DI: 7445161SilkPlusZen8Z
Reference: RSM-125+Z
EMDN: P0601010201
EMDN description: BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country: Belgium
Safety summary (SSCP/SSP): SSCP-00100 · Rev. 8
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Motiva Implants Round VelvetSurface Plus with Zen

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161007278
Basic UDI-DI: 7445161VelvetPlusZenEJ
Reference: RVM-125+Z
EMDN: P0601010202
EMDN description: BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country: Belgium
Safety summary (SSCP/SSP): SSCP-001004 · Rev. 1
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:36

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Motiva Implants Round VelvetSurface Plus

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161004819
Basic UDI-DI: 7445161VelvetPlus62
Reference: RVM-125+
EMDN: P0601010202
EMDN description: BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE
First on market country: Belgium
Safety summary (SSCP/SSP): SSCP-001004 · Rev. 1
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:35

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Motiva Implants

Motiva Implants Round SmoothSilk/SilkSurface Plus

Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile

Manufacturer: Establishment Labs
Manufacturer SRN: CR-MF-000008155
UDI-DI: 07445161001610
Basic UDI-DI: 7445161SilkPlusS4
Reference: RSM-125+
EMDN: P0601010201
EMDN description: BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
First on market country: Belgium
Safety summary (SSCP/SSP): SSCP-00100 · Rev. 8
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 05:35

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Sterile Customized ProcedurePak

Class IIIMDR 2017/745Not intended for EU marketSterile

Manufacturer: Mölnlycke Health Care AB
Manufacturer SRN: SE-PR-000016902
UDI-DI: 07313662499680
Basic UDI-DI: 733243000000000143JX
Reference: 97156502-00
EMDN: V0599
EMDN description: CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 05:30

Manufacturer products View details

Sterile Customized ProcedurePak

Class IIIMDR 2017/745On the marketSterile

Manufacturer: Mölnlycke Health Care AB
Manufacturer SRN: SE-PR-000016902
UDI-DI: 07313662475455
Basic UDI-DI: 733243000000000131JQ
Reference: 97142841-02
EMDN: V0599
EMDN description: CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 05:30

Manufacturer products View details

Sterile Customized ProcedurePak

Class IIIMDR 2017/745On the marketSterile

Manufacturer: Mölnlycke Health Care AB
Manufacturer SRN: SE-PR-000016902
UDI-DI: 07313662465845
Basic UDI-DI: 733243000000000147K7
Reference: 97116464-04
EMDN: V0599
EMDN description: CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 05:30

Manufacturer products View details