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

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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: 07445161015402
Basic UDI-DI: 7445161Ergo2AX
Reference: E2SM-95
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: 16.07.2026 11:38

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: 07445161011060
Basic UDI-DI: 7445161ErgoVelvetM5
Reference: ERVM-105
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: 16.07.2026 11:38

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: 07445161010261
Basic UDI-DI: 7445161ErgoroundR5
Reference: ERSM-105
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: 16.07.2026 11:38

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: 07445161009289
Basic UDI-DI: 7445161Ergo2ZenBQ
Reference: DSM-100Z
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: 16.07.2026 11:38

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: 07445161008060
Basic UDI-DI: 7445161ErgoroundZen8Y
Reference: ERSM-105Z
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: 16.07.2026 11:38

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: 07445161007261
Basic UDI-DI: 7445161VelvetPlusZenEJ
Reference: RVM-105+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: 16.07.2026 11:38

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: 07445161006462
Basic UDI-DI: 7445161SilkPlusZen8Z
Reference: RSM-105+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: 16.07.2026 11:37

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: 07445161004802
Basic UDI-DI: 7445161VelvetPlus62
Reference: RVM-105+
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: 16.07.2026 11:37

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: 07445161001603
Basic UDI-DI: 7445161SilkPlusS4
Reference: RSM-105+
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: 16.07.2026 11:37

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

Swabable Vial Adapter™

Swabable Vial Adapter™

Class IMDR 2017/745On the marketSterile

Manufacturer: West Pharma. Services IL, Ltd.
Manufacturer SRN: IL-MF-000008572
UDI-DI: 07290108241686
Basic UDI-DI: 729010824SVA20VFG5
Reference: 8072022
EMDN: A0704
EMDN description: SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Swabable Vial Adapter™

Swabable Vial Adapter™

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: West Pharma. Services IL, Ltd.
Manufacturer SRN: IL-MF-000008572
UDI-DI: 07290108241679
Basic UDI-DI: 729010824SVA20SFFU
Reference: 8072001
EMDN: A0704
EMDN description: SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Swabable Vial Adapter™

Swabable Vial Adapter™

Class IMDR 2017/745On the marketSterile

Manufacturer: West Pharma. Services IL, Ltd.
Manufacturer SRN: IL-MF-000008572
UDI-DI: 07290108241662
Basic UDI-DI: 729010824SVA13VFGD
Reference: 8070101
EMDN: A0704
EMDN description: SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 11:31

Manufacturer products Authorised representative products Authorised representative actors View details

Contour comfort

Plus Pro

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sandstone Medical(Suzhou) Inc.
Manufacturer SRN: CN-MF-000011105
UDI-DI: 06972857296124
Basic UDI-DI: 697285729042A
Reference: 04-3204
EMDN: A0101010202
EMDN description: HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

Ureteral Access Sheaths

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Innovex Medical Co., Ltd.
Manufacturer SRN: CN-MF-000015981
UDI-DI: 06950203341087
Basic UDI-DI: 69502033NSCA
Reference: IVX-NS-1055
EMDN: U020199
EMDN description: URETERAL CATHETERS WITHOUT BALLOON - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable Blood Lancets

Class IIaMDR 2017/745Not intended for EU marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630144711
Basic UDI-DI: 6945630101B9
Reference: Soft 28G
EMDN: V010402
EMDN description: LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable Steel Lancets

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630144650
Basic UDI-DI: 6945630150BN
Reference: "Steel 50-0101"
EMDN: V010402
EMDN description: LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country: Bulgaria
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable Safety Lancets

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630116800
Basic UDI-DI: 6945630105BH
Reference: 49956 Flex3 28G
EMDN: V010401
EMDN description: LANCETS WITH SAFETY SYSTEMS, SINGLE-USE
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

PV 5 Disposable Non - Rebreathing Valve

Disposable Valve & Manifold

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 46923980110373
Basic UDI-DI: 69239801ND2RDQ7
Reference: XTA0003
EMDN: R028001
EMDN description: RESPIRATORY CIRCUITS VALVES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 10:34

Manufacturer products Authorised representative products Authorised representative actors View details

OT-1 Oxygen Tubing 2M

Disposable Oxygen tubing

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 46923980110182
Basic UDI-DI: 69239801ND2NBPP
Reference: XTA0016
EMDN: R03010204
EMDN description: OXYGEN ADMINISTRATION TUBINGS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 10:34

Manufacturer products Authorised representative products Authorised representative actors View details

Latex Free Breathing Bag 0.5L

Disposable Breathing bag

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 46923980109827
Basic UDI-DI: 69239801ND2CBNN
Reference: XTA0035
EMDN: R028099
EMDN description: RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 10:34

Manufacturer products Authorised representative products Authorised representative actors View details