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VITREX

Disposable Safety Lancets

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630119771
Basic UDI-DI: 6945630105BH
Reference: 396413
EMDN: V010401
EMDN description: LANCETS WITH SAFETY SYSTEMS, SINGLE-USE
First on market country: Denmark
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors 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: 07445161025043
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OC-320T
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 10:45

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: 07445161024497
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OC-320Z
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 10:45

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

VITREX

Disposable Safety Lancets

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630119764
Basic UDI-DI: 6945630105BH
Reference: 395413
EMDN: V010401
EMDN description: LANCETS WITH SAFETY SYSTEMS, SINGLE-USE
First on market country: Denmark
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors 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: 07445161025036
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OC-270T
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 10:41

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: 07445161024480
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OC-270Z
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 10:41

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

VITREX

Disposable Safety Lancets

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630119757
Basic UDI-DI: 6945630105BH
Reference: 394413
EMDN: V010401
EMDN description: LANCETS WITH SAFETY SYSTEMS, SINGLE-USE
First on market country: Denmark
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 10:38

Manufacturer products Authorised representative products Authorised representative actors 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: 07445161025029
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OC-210T
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 10:37

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: 07445161024473
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OC-210Z
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 10:37

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

VITREX

Disposable Safety Lancets

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630119740
Basic UDI-DI: 6945630105BH
Reference: 393413
EMDN: V010401
EMDN description: LANCETS WITH SAFETY SYSTEMS, SINGLE-USE
First on market country: Denmark
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 10:34

Manufacturer products Authorised representative products Authorised representative actors 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: 07445161025012
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OC-175T
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 10:33

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: 07445161024466
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OC-175Z
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 10:33

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

16945630119702

Disposable Safety Lancets

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630119702
Basic UDI-DI: 6945630105BH
Reference: 05-232818 Press Plus 28G 1.8mm
EMDN: V010401
EMDN description: LANCETS WITH SAFETY SYSTEMS, SINGLE-USE
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 10:30

Manufacturer products Authorised representative products Authorised representative actors 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: 07445161025005
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OF-860T
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 10:29

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: 07445161024459
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OF-860Z
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 10:29

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

STERILANCE

Disposable Safety Lancets

Class IIaMDR 2017/745Not intended for EU marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630119696
Basic UDI-DI: 6945630105BH
Reference: 05-062818 Press2 28G 1.8mm
EMDN: V010401
EMDN description: LANCETS WITH SAFETY SYSTEMS, SINGLE-USE
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 10:26

Manufacturer products Authorised representative products Authorised representative actors 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: 07445161024992
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OF-770T
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 10:25

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: 07445161024442
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OF-770Z
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 10:25

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

16945630119573

Disposable Safety Lancets

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630119573
Basic UDI-DI: 6945630105BH
Reference: 05 - 232122 (GIMA 24461)
EMDN: V010401
EMDN description: LANCETS WITH SAFETY SYSTEMS, SINGLE-USE
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 10:22

Manufacturer products Authorised representative products Authorised representative actors 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: 07445161024985
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OF-695T
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 10:21

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