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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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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

Adult Small Disposable Masks

6625

Class IMDR 2017/745On the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333231041
Basic UDI-DI: 496133303A6625VH
Reference: 6625
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

Pediatric Disposable Masks

6615

Class IMDR 2017/745On the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333231034
Basic UDI-DI: 496133303A6615VE
Reference: 6615
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

Cardboard Tubes (Disposable)

6610

Class IMDR 2017/745On the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333230105
Basic UDI-DI: 496133303A6610V4
Reference: 6610
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

Pediatric Mask with Adaptor

6606

Class IMDR 2017/745On the market

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333230099
Basic UDI-DI: 496133303A6606VD
Reference: 6606
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

Adult Face Mask, Extra

6602

Class IMDR 2017/745On the market

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333230082
Basic UDI-DI: 496133303A6602V5
Reference: 6602
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:27

Manufacturer products Authorised representative products Authorised representative actors View details

Flowhead, Extra

6601

Class IMDR 2017/745On the market

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333230075
Basic UDI-DI: 496133303A6601V3
Reference: 6601
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:27

Manufacturer products Authorised representative products Authorised representative actors View details

Intra‑Oral Tubes

6611

Class IMDR 2017/745On the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333229918
Basic UDI-DI: 496133303A6611V6
Reference: 6611
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:27

Manufacturer products Authorised representative products Authorised representative actors View details

04745010564062

McCormick rattle

Class IMDR 2017/745On the market

Manufacturer: 1M4 OÜ
Manufacturer SRN: EE-MF-000040367
UDI-DI: 04745010564062
Basic UDI-DI: 474501056410006BC
Reference: 10006.00
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Estonia
Authorised representative: -
Last updated: 31.07.2026 06:55

Manufacturer products View details

audioboX 6 Kanäle

51050005

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Merz Medizintechnik GmbH
Manufacturer SRN: DE-MF-000010619
UDI-DI: 04260585410243
Basic UDI-DI: 42605854142605854101993W
Reference: 51050015
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:28

Manufacturer products View details

MERZ Drehstuhl mit Excenter

52000000

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Merz Medizintechnik GmbH
Manufacturer SRN: DE-MF-000010619
UDI-DI: 04260585411745
Basic UDI-DI: 42605854142605854116844H
Reference: 52000001
EMDN: Z12140403
EMDN description: ROTATING PENDULAR CHAIRS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:21

Manufacturer products View details

Audiometrie-Lautsprecher AM-4

51050005

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Merz Medizintechnik GmbH
Manufacturer SRN: DE-MF-000010619
UDI-DI: 04260585410236
Basic UDI-DI: 42605854142605854101993W
Reference: 51050001
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:21

Manufacturer products View details

Merz Drehstuhl

52000000

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Merz Medizintechnik GmbH
Manufacturer SRN: DE-MF-000010619
UDI-DI: 04260585411684
Basic UDI-DI: 42605854142605854116844H
Reference: 52000000
EMDN: Z12140403
EMDN description: ROTATING PENDULAR CHAIRS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:12

Manufacturer products View details

Merz Audio

51050005

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Merz Medizintechnik GmbH
Manufacturer SRN: DE-MF-000010619
UDI-DI: 04260585410199
Basic UDI-DI: 42605854142605854101993W
Reference: 51050005
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:11

Manufacturer products View details