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

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01.08.2026 01:12

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Unicare

Class IIaMDR 2017/745On the marketNo EU rep

Manufacturer: TensCare Ltd
Manufacturer SRN: UK-PR-000039358
UDI-DI: 05033435135646
Basic UDI-DI: 5033435K00130ZC
Reference: K-UNICARE
EMDN: U070399
EMDN description: PELVIC FLOOR REHABILITATION DEVICES - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 12:37

Manufacturer products View details

Bulkamid® Urethral Bulking System

Class IIbMDR 2017/745On the market

Manufacturer: Contura International A/S
Manufacturer SRN: DK-PR-000002019
UDI-DI: 05704101500128
Basic UDI-DI: 5704101500124Q
Reference: 50012
EMDN: U070199
EMDN description: INTERNAL SYSTEMS FOR THE TREATMENT OF INCONTINENCE - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 11:58

Manufacturer products View details

Bulkamid® Rotatable Sheath

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Contura International A/S
Manufacturer SRN: DK-MF-000002018
UDI-DI: 05704101100472
Basic UDI-DI: 5704101BURSY8
Reference: 10047
EMDN: U0780
EMDN description: DEVICES FOR THE TREATMENT OF INCONTINENCE - ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 11:58

Manufacturer products View details

Bulkamid® Needle

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Contura International A/S
Manufacturer SRN: DK-MF-000002018
UDI-DI: 05704101014915
Basic UDI-DI: 5704101BUNEWY
Reference: 10001491
EMDN: U0780
EMDN description: DEVICES FOR THE TREATMENT OF INCONTINENCE - ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 11:58

Manufacturer products View details

Bulkamid® Hydrogel

Class IIbMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Contura International A/S
Manufacturer SRN: DK-MF-000002018
UDI-DI: 05704101500098
Basic UDI-DI: 5704101BulkamidCG
Reference: 50009
EMDN: U070199
EMDN description: INTERNAL SYSTEMS FOR THE TREATMENT OF INCONTINENCE - OTHER
First on market country: Netherlands
Safety summary (SSCP/SSP): 018.SSCP.00025.01 · Rev. Rev. 004
Authorised representative: -
Last updated: 31.07.2026 11:58

Manufacturer products Open in EUDAMED View details

Ugo Catheter Valve

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Optimum Medical Solutions Ltd.
Manufacturer SRN: GB-MF-000005194
UDI-DI: 05060222471625
Basic UDI-DI: 506022247VALVE4V
Reference: 3000
EMDN: U0780
EMDN description: DEVICES FOR THE TREATMENT OF INCONTINENCE - ACCESSORIES
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

GB Libra Sheath

Sheath

Class IMDR 2017/745On the marketSingle use

Manufacturer: Clinisupplies GB Limited
Manufacturer SRN: GB-MF-000023993
UDI-DI: 05060152310711
Basic UDI-DI: 506015231TF0009N2
Reference: GBLSS24
EMDN: U070201
EMDN description: SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE
First on market country: Ireland
Authorised representative: MD REPS Ltd
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

Prosys Flofit Self Adhesive Silicon Sheath-Std, 24mm

UROLOGY

Class IMDR 2017/745On the marketSingle use

Manufacturer: Clinisupplies Ltd
Manufacturer SRN: GB-MF-000023783
UDI-DI: 05036100005688
Basic UDI-DI: 50361000U0017P
Reference: PSS24STD/B
EMDN: U070201
EMDN description: SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

Perfect PFE for Men

Perfect PFE

Class IIaMDR 2017/745On the marketActive device

Manufacturer: TensCare Ltd
Manufacturer SRN: GB-MF-000004156
UDI-DI: 05033435139743
Basic UDI-DI: 5033435K00053ZK
Reference: K-PPFE-MEN
EMDN: U070399
EMDN description: PELVIC FLOOR REHABILITATION DEVICES - OTHER
First on market country: Poland
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

iTouch Sure 2 (ES FR DE IT)

iTouch Sure 2

Class IIaMDR 2017/745On the marketActive device

Manufacturer: TensCare Ltd
Manufacturer SRN: GB-MF-000004156
UDI-DI: 05033435136971
Basic UDI-DI: 5033435K00030Z7
Reference: K-ITS (ES FR DE IT)
EMDN: U070399
EMDN description: PELVIC FLOOR REHABILITATION DEVICES - OTHER
First on market country: Spain
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Sure PRO

Class IIaMDR 2017/745On the marketActive device

Manufacturer: TensCare Ltd
Manufacturer SRN: GB-MF-000004156
UDI-DI: 05033435136414
Basic UDI-DI: 5033435K00072DSP
Reference: K-SP
EMDN: U070399
EMDN description: PELVIC FLOOR REHABILITATION DEVICES - OTHER
First on market country: Poland
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Unicare

Class IIaMDR 2017/745On the marketActive device

Manufacturer: TensCare Ltd
Manufacturer SRN: GB-MF-000004156
UDI-DI: 05033435136285
Basic UDI-DI: 5033435K00130DS4
Reference: K-UNICARE
EMDN: U070399
EMDN description: PELVIC FLOOR REHABILITATION DEVICES - OTHER
First on market country: Poland
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Alivia

Class IIaMDR 2017/745On the marketActive device

Manufacturer: TensCare Ltd
Manufacturer SRN: GB-MF-000004156
UDI-DI: 05033435136278
Basic UDI-DI: 5033435K00138DSU
Reference: K-ALIVIA
EMDN: U070399
EMDN description: PELVIC FLOOR REHABILITATION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Alivia

Class IIaMDR 2017/745On the marketNo EU rep

Manufacturer: TensCare Ltd
Manufacturer SRN: UK-PR-000039358
UDI-DI: 05033435135967
Basic UDI-DI: 5033435K00138ZU
Reference: K-ALIVIA
EMDN: U070399
EMDN description: PELVIC FLOOR REHABILITATION DEVICES - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 07:55

Manufacturer products View details

CliniSure Urinary Sheath Pop On 24mm

CliniSure Urinary Sheath

Class IMDR 2017/745On the marketSingle use

Manufacturer: CliniMed Limited
Manufacturer SRN: GB-MF-000023784
UDI-DI: 05017950000214
Basic UDI-DI: 5017950CliniSureSheathMJ
Reference: CS24P
EMDN: U070201
EMDN description: SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE
First on market country: Ireland
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

Empelvic

Empelvic male

Class IMDR 2017/745On the market

Manufacturer: Owen Mumford Ltd
Manufacturer SRN: GB-MF-000021000
UDI-DI: 05016189618337
Basic UDI-DI: 5016189EMPELVIC3G
Reference: OM-006183
EMDN: U070399
EMDN description: PELVIC FLOOR REHABILITATION DEVICES - OTHER
First on market country: Germany
Authorised representative: Owen Mumford GmbH
Last updated: 31.07.2026 07:48

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalkondom

Male External Catheter

Class IMDR 2017/745On the marketSingle use

Manufacturer: First Global Enterprises Limited
Manufacturer SRN: HK-MF-000022525
UDI-DI: 04897043855027
Basic UDI-DI: 489704385FGE3A0FQ
Reference: 3A0125
EMDN: U070201
EMDN description: SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 07:13

Manufacturer products Authorised representative products Authorised representative actors View details

Supersoft

Silicone External Catheter

Class IMDR 2017/745On the marketSingle use

Manufacturer: Dileh Medical supplies co., Ltd.
Manufacturer SRN: TW-MF-000016927
UDI-DI: 04716820130280
Basic UDI-DI: 471682013693410HW
Reference: 30013
EMDN: U070201
EMDN description: SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE
First on market country: Greece
Authorised representative: Umedwings Netherlands B.V.
Last updated: 31.07.2026 06:42

Manufacturer products Authorised representative products Authorised representative actors View details

Supersoft

Silicone External Catheter

Class IMDR 2017/745On the marketReprocessedSingle use

Manufacturer: Dileh Medical supplies co., Ltd.
Manufacturer SRN: TW-MF-000016927
UDI-DI: 04716820130235
Basic UDI-DI: 471682013693410HW
Reference: 30006
EMDN: U070201
EMDN description: SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE
First on market country: Greece
Authorised representative: Umedwings Netherlands B.V.
Last updated: 31.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

dres kegel

HNJ-1000

Class IMDR 2017/745On the marketActive device

Manufacturer: SmartMann GmbH
Manufacturer SRN: DE-MF-000049779
UDI-DI: 04262560510023
Basic UDI-DI: 426256HNJ-1000LQ
Reference: SMM-CA0508-2K504
EMDN: U070301
EMDN description: PELVIC FLOOR REHABILITATION DEVICES, BIOFEEDBACK, SINGLE-USE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:43

Manufacturer products View details