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CPK SHOULDER ROLL

Class IMDR 2017/745On the market

Manufacturer: FARMABAN s.a.
Manufacturer SRN: ES-MF-000004713
UDI-DI: 08428012016451
Basic UDI-DI: 8428012ORTESISSHORFD
Reference: 1645
EMDN: Y210924
EMDN description: ARM SUPPORTS
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:11

Manufacturer products View details

SATURNO

Apparecchi acustici

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Linear S.r.l.
Manufacturer SRN: IT-MF-000026754
UDI-DI: 08058480620005
Basic UDI-DI: 805848062appacustici01K6
Reference: SA
EMDN: Y2145060202
EMDN description: HEARING AIDS IN-THE-CANAL (ITC)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 12:09

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TG-8

TimeGuide

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: LVI Low Vision International AB
Manufacturer SRN: SE-MF-000004178
UDI-DI: 07330724005610
Basic UDI-DI: 7330724TGTA
Reference: TG-8
EMDN: Y215199
EMDN description: ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 16.07.2026 11:33

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Hearing Aid

5118DL/5118L/5120L/5122L/5124L/5126L/5128L/5130L/5112L/5116L/5216L/3308/1118/1120/1122 /1124/1216/6118/6120/6121/6122/6126/6128

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Tmore Medical （Shenzhen）Co. Ltd
Manufacturer SRN: CN-MF-000056293
UDI-DI: 06976110832708
Basic UDI-DI: 697611083HR001CF
Reference: 5118DL
EMDN: Y2145060101
EMDN description: BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)
First on market country: Germany
Authorised representative: Humiss Beratung GmbH
Last updated: 16.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

06972019043511

mixed

Class IMDR 2017/745On the market

Manufacturer: WENZHOU PILOT OPTICS CORP.,LTD.
Manufacturer SRN: CN-MF-000001279
UDI-DI: 06972019043511
Basic UDI-DI: 697201904RXFQY
Reference: 321508
EMDN: Y210330
EMDN description: MAGNIFYING ACHROMATIC DOUBLET LENSES
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

Tik-Tak Pro

Class IMDR 2017/745On the marketActive device

Manufacturer: UHURA BIONICS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
Manufacturer SRN: PL-MF-000056617
UDI-DI: 05908809923801
Basic UDI-DI: 59088099238Tik-Tak_ProKV
Reference: Tik Tak Pro 1
EMDN: Y214212
EMDN description: VOICE GENERATORS
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:23

Manufacturer products View details

AURILAB

BTE Hearing Tubes

Class IMDR 2017/745On the marketSingle use

Manufacturer: "K&K CONSULTING" Krzysztof Kalinowicz
Manufacturer SRN: PL-MF-000056504
UDI-DI: 05908023854400
Basic UDI-DI: 59080238554DW8S
Reference: DW-A
EMDN: Y214580
EMDN description: HEARING AIDS OR HEARING DEVICES - ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:22

Manufacturer products View details

Smoothie 125 Red (Large Jack)

Assistive Switches

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Pretorian Technologies Ltd
Manufacturer SRN: GB-MF-000008344
UDI-DI: 05060895630817
Basic UDI-DI: 506089563SWS1H6
Reference: SMOO5LJR
EMDN: Y214299
EMDN description: DEVICES FOR INTERPERSONAL COMUNICATION - OTHER
First on market country: Ireland
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 16.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Optimax Trackball

Trackballs and Trackpads

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Pretorian Technologies Ltd
Manufacturer SRN: GB-MF-000008344
UDI-DI: 05060895630145
Basic UDI-DI: 506089563TKB1DW
Reference: Optimax Trackball
EMDN: Y210906
EMDN description: MOUSE AND KEYBOARD EMULATORS
First on market country: Ireland
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 16.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

BED ALERTAMAT ONLY

Alerta Bed Mat, Wireless c/w Transmitter

Class IMDR 2017/745On the market

Manufacturer: Alerta Medical Ltd
Manufacturer SRN: GB-MF-000013708
UDI-DI: 05060614530114
Basic UDI-DI: 506061453FallPreventionLJ
Reference: BAM
EMDN: Y215199
EMDN description: ALARM SYSTEMS + SIGNALING, INDICATION AND REMINDER AIDS - OTHER
First on market country: Ireland
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 16.07.2026 09:49

Manufacturer products Authorised representative products Authorised representative actors View details

Helix

ITEKIT Hearing Aids Series

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Ear-Technic GmbH
Manufacturer SRN: DE-MF-000043916
UDI-DI: 04262451171265
Basic UDI-DI: 426245117ITE283
Reference: 142D01-02350196
EMDN: Y2145060201
EMDN description: HEARING AID IN THE-EAR (ITE)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:21

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Earnet

BTE Hearing Aids Series

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Ear-Technic GmbH
Manufacturer SRN: DE-MF-000043916
UDI-DI: 04262451170657
Basic UDI-DI: 426245117BTE16G
Reference: 142D02 - 01350173
EMDN: Y2145060101
EMDN description: BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:21

Manufacturer products View details

Helix

TIE Hearing Aids Series

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Ear-Technic GmbH
Manufacturer SRN: DE-MF-000043916
UDI-DI: 04262451170039
Basic UDI-DI: 426245117TIE18P
Reference: 160D02 - 07010136
EMDN: Y2145060201
EMDN description: HEARING AID IN THE-EAR (ITE)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:21

Manufacturer products View details

Verbindungsbox - VIO®

Footswitch junction box for VIO

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Erbe Elektromedizin GmbH
Manufacturer SRN: DE-MF-000005498
UDI-DI: 04050147023512
Basic UDI-DI: 4050147JunctionBoxVIO-WN
Reference: 20160-012
EMDN: Y210999
EMDN description: PERSONAL COMPUTER INPUT AND OUTPUT PERIPHERAL EQUIPMENT - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 08:30

Manufacturer products View details

Leukoplast®

Leukoplast® eye occlusor

Class IMDR 2017/745On the marketSingle use

Manufacturer: BSN medical GmbH
Manufacturer SRN: DE-MF-000005787
UDI-DI: 04042809687491
Basic UDI-DI: 4042809400386179W
Reference: 76467-00
EMDN: Y210336
EMDN description: OCCLUSION AND ANTI-RADIATION FILTERS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 08:21

Manufacturer products View details

Parlez™ Electrolarynx

Parlez Electrolarynx Family

Class IMDR 2017/745On the marketActive device

Manufacturer: Elogio Speech Technologies LLC
Manufacturer SRN: US-MF-000052790
UDI-DI: 00860012896806
Basic UDI-DI: 08600128968PARLEZEL55
Reference: PARLEZ
EMDN: Y214299
EMDN description: DEVICES FOR INTERPERSONAL COMUNICATION - OTHER
First on market country: Germany
Authorised representative: Europecert UG (haftungsbeschränkt)
Last updated: 16.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

GoTalk 20+ Lite Touch

GoTalk

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Attainment Company, Inc.
Manufacturer SRN: US-MF-000043650
UDI-DI: 00860011726708
Basic UDI-DI: 08600117268GTVJ
Reference: GTL-20
EMDN: Y214212
EMDN description: VOICE GENERATORS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 16.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

10850057368007

ElectroLarynx

Class IMDR 2017/745On the marketActive deviceSingle use

Manufacturer: ENT Solutions LLC
Manufacturer SRN: US-MF-000037670
UDI-DI: 10850057368007
Basic UDI-DI: 0850057368ElectroLarynxD2
Reference: EL 1000
EMDN: Y214212
EMDN description: VOICE GENERATORS
First on market country: Netherlands
Authorised representative: QNET B.V.
Last updated: 16.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

Focus 640

F640-UMMS

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Enhanced Vision Systems, Inc
Manufacturer SRN: US-MF-000037120
UDI-DI: 08500183433982
Basic UDI-DI: 0850018343FOCUS6W6
Reference: F640-UMMS
EMDN: Y2199
EMDN description: COMMUNICATION AND INFORMATION MANAGEMENT AIDS - OTHER
First on market country: Netherlands
Authorised representative: Optelec Nederland B.V.
Last updated: 16.07.2026 06:27

Manufacturer products Authorised representative products Authorised representative actors View details

Compact 8

Class IMDR 2017/745On the marketActive device

Manufacturer: Optelec Nederland B.V.
Manufacturer SRN: NL-MF-000027675
UDI-DI: 00850017300576
Basic UDI-DI: 0850017300CP8UU
Reference: CP8-UMME
EMDN: Y210603
EMDN description: VIDEO MAGNIFIERS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 06:13

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