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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: 07445161024435
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OF-695Z
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

16945630119566

Disposable Safety Lancets

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630119566
Basic UDI-DI: 6945630105BH
Reference: 05 - 232818 (GIMA 24465)
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 10:18

Manufacturer products Authorised representative products Authorised representative actors 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: 07445161024428
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OF-620Z
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 10:17

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: 07445161024978
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OF-620T
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 10:17

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

16945630119559

Disposable Safety Lancets

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630119559
Basic UDI-DI: 6945630105BH
Reference: 05 - 232318 (GIMA 24463)
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 10:14

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: 07445161024961
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OF-550T
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 10:13

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: 07445161024411
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OF-550Z
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 10:13

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: 16945630119467
Basic UDI-DI: 6945630105BH
Reference: 399213 Press2 30G 1.8mm
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 10:10

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: 07445161024954
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OF-510T
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 10:09

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: 07445161024404
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OF-510Z
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 10:09

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: 16945630119450
Basic UDI-DI: 6945630105BH
Reference: 398213 Press2 28G 1.8mm
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 10:06

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: 07445161024947
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OF-460T
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 10:05

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: 07445161024398
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OF-460Z
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 10:05

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: 16945630119443
Basic UDI-DI: 6945630105BH
Reference: 394213 Press2 26G 1.8mm
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 10:03

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: 07445161024930
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OF-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: Belgium
Safety summary (SSCP/SSP): SSCP-001003 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 10:02

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: 07445161024381
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OF-395Z
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 10:02

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: 16945630119436
Basic UDI-DI: 6945630105BH
Reference: 396213 Press2 21G 2.8mm
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 09:58

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: 07445161024923
Basic UDI-DI: 7445161Ergo2OvalZenTempPQ
Reference: E2OF-330T
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 09:57

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: 07445161024374
Basic UDI-DI: 7445161Ergo2OvalZenMP
Reference: E2OF-330Z
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 09:57

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: 16945630119429
Basic UDI-DI: 6945630105BH
Reference: 395213 Press2 21G 2.2mm
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 09:54

Manufacturer products Authorised representative products Authorised representative actors View details