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EUDAMED Device Search

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

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31.07.2026 18:33

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Headset ME70 (12 kHz)

8-75-790

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315000638
Basic UDI-DI: 5713315NA000795X
Reference: 8‑75‑260
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

1066 MADSEN Astera 2

MADSEN Astera 2

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315000577
Basic UDI-DI: 5713315NA000385H
Reference: 8-04-13102
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

05713315000058

1052 Otosuite Accessory

Class IIaMDR 2017/745On the market

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315000058
Basic UDI-DI: 5713315NA000755P
Reference: 8-49-75800
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

Lenire Tonguetip

TP-101

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Neuromod Devices Limited
Manufacturer SRN: IE-MF-000004261
UDI-DI: 05391540580080
Basic UDI-DI: 539154058TP-101-EU3ZJ
Reference: EU3
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 10:02

Manufacturer products View details

Lenire Tonguetip

TP-101

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Neuromod Devices Limited
Manufacturer SRN: IE-MF-000004261
UDI-DI: 05391540580073
Basic UDI-DI: 539154058TP-101-EU2ZG
Reference: EU2
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 10:02

Manufacturer products View details

Lenire Tonguetip

TP-101

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Neuromod Devices Limited
Manufacturer SRN: IE-MF-000004261
UDI-DI: 05391540580066
Basic UDI-DI: 539154058TP-101-EU1ZE
Reference: EU1
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 10:02

Manufacturer products View details

Lenire

SM-301

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Neuromod Devices Limited
Manufacturer SRN: IE-MF-000004261
UDI-DI: 05391540580059
Basic UDI-DI: 539154058SM-301-EU3XJ
Reference: EU3
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 10:00

Manufacturer products View details

Lenire

SM-301

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Neuromod Devices Limited
Manufacturer SRN: IE-MF-000004261
UDI-DI: 05391540580042
Basic UDI-DI: 539154058SM-301-EU2XG
Reference: EU2
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 10:00

Manufacturer products View details

Lenire

SM-301

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Neuromod Devices Limited
Manufacturer SRN: IE-MF-000004261
UDI-DI: 05391540580035
Basic UDI-DI: 539154058SM-301-EU1XE
Reference: EU1
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 10:00

Manufacturer products View details

Examination cabinet

ENTCmi0102

Class IMDR 2017/745On the marketDirect marking

Manufacturer: ΠΑΠΠΑΣ Ν. & ΣΙΑ ΟΕ
Manufacturer SRN: GR-MF-000016242
UDI-DI: 05214002308100
Basic UDI-DI: 5214002308ENTCmi0201T6
Reference: ENTCmi0201
EMDN: Z121402
EMDN description: ENT TREATMENT UNITS
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:47

Manufacturer products View details

Examination cabinet

ENTC0102w

Class IMDR 2017/745On the marketDirect marking

Manufacturer: ΠΑΠΠΑΣ Ν. & ΣΙΑ ΟΕ
Manufacturer SRN: GR-MF-000016242
UDI-DI: 05214002308094
Basic UDI-DI: 5214002308ENTC0102wBQ
Reference: ENTC0102w
EMDN: Z121402
EMDN description: ENT TREATMENT UNITS
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:47

Manufacturer products View details

05065005841053

WAXscope kit

Class IMDR 2017/745On the marketNo EU rep

Manufacturer: Clearwax Ltd
Manufacturer SRN: GB-PR-000032246
UDI-DI: 05065005841053
Basic UDI-DI: 5065005841WSK64
Reference: 5065005841053
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 09:15

Manufacturer products View details

WAXscope

Clearwax Earwax Visualisation Devices

Class IMDR 2017/745On the market

Manufacturer: Clearwax Ltd
Manufacturer SRN: GB-MF-000010886
UDI-DI: 05065005841046
Basic UDI-DI: 5065005841WSCN
Reference: 5065005841046
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 31.07.2026 09:15

Manufacturer products Authorised representative products Authorised representative actors View details

05065005841022

iCLEARscope kit

Class IMDR 2017/745On the marketNo EU rep

Manufacturer: Clearwax Ltd
Manufacturer SRN: GB-PR-000032246
UDI-DI: 05065005841022
Basic UDI-DI: 5065005841ICS2W
Reference: 5065005841022
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 09:15

Manufacturer products View details

CLEARscope

Clearwax Earwax Visualisation Devices

Class IMDR 2017/745On the marketReusable

Manufacturer: Clearwax Ltd
Manufacturer SRN: GB-MF-000010886
UDI-DI: 05065005841008
Basic UDI-DI: 5065005841CSAS
Reference: 5065005841008
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 31.07.2026 09:15

Manufacturer products Authorised representative products Authorised representative actors View details

Tympa Otoscope System (iPhone XR)

Tympa Otoscope System

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Tympa Health Technologies Ltd
Manufacturer SRN: UK-MF-000042174
UDI-DI: 15060753520004
Basic UDI-DI: 506075352GEN2OTOAB
Reference: THiXR02
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

2.8V POCKET OTO IN CASE

Keeler Otoscopes

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Keeler Ltd
Manufacturer SRN: GB-MF-000009031
UDI-DI: 05055272701914
Basic UDI-DI: 50552727OTOSCOPESVJ
Reference: 1503-P-1034
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Spain
Authorised representative: Keeler Europe Distribution, S.L.
Last updated: 31.07.2026 08:08

Manufacturer products Authorised representative products Authorised representative actors View details

Microphone Assembly Kit

6651

Class IMDR 2017/745On the marketActive device

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333255979
Basic UDI-DI: 496133303A6651VJ
Reference: 6651
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:28

Manufacturer products Authorised representative products Authorised representative actors View details

Phonatory Aerodynamic System (SOFTWARE)

6600

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333236565
Basic UDI-DI: 496133303660026
Reference: 6600WU
EMDN: Z12149010
EMDN description: VOICE DISPLAYS
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:28

Manufacturer products Authorised representative products Authorised representative actors View details

Switch Box Assembly A‑B

7190-2500

Class IMDR 2017/745On the market

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333231553
Basic UDI-DI: 496133303A7190VA
Reference: 7190‑2500
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:28

Manufacturer products Authorised representative products Authorised representative actors View details