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

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BC-RE1

Bone conductor

Class IIaMDR 2017/745On the marketActive device

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223140891
Basic UDI-DI: 0426022BoneConductor-2aTS
Reference: 100214
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:39

Manufacturer products View details

PT-A

100120

Class IIaMDR 2017/745On the marketActive deviceSingle use

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223140051
Basic UDI-DI: 0426022Probes-2aTM
Reference: 100013
EMDN: Z12140380
EMDN description: EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:39

Manufacturer products View details

MicroFrance®

Instrument Holder

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Integra MicroFrance
Manufacturer SRN: FR-MF-000011524
UDI-DI: 10381780104896
Basic UDI-DI: 038178B0055CSS3U
Reference: MCL112H
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 15.07.2026 23:28

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MicroFrance®

Tension Arm

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Integra MicroFrance
Manufacturer SRN: FR-MF-000011524
UDI-DI: 10381780097419
Basic UDI-DI: 038178B0045CSS3H
Reference: CEV980-3
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 15.07.2026 23:28

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Protektor32 Auditory Stimulation Headphones

Class IMDR 2017/745On the marketDirect marking

Manufacturer: NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK)
Manufacturer SRN: CA-MF-000004001
UDI-DI: 00382830011259
Basic UDI-DI: 0382830058988VP
Reference: 005032
EMDN: Z12140380
EMDN description: EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Natus Manufacturing Ltd
Last updated: 15.07.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

Protektor 32 Ear Inserts

Class IMDR 2017/745On the marketDirect marking

Manufacturer: NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK)
Manufacturer SRN: CA-MF-000004001
UDI-DI: 00382830011013
Basic UDI-DI: 0382830058995VL
Reference: 005562
EMDN: Z12140380
EMDN description: EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Natus Manufacturing Ltd
Last updated: 15.07.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

00195949149948

Hearing Test Feature

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Apple Inc.
Manufacturer SRN: US-MF-000013709
UDI-DI: 00195949149948
Basic UDI-DI: 0195949HTTV
Reference: Hearing Test Feature 1.X
EMDN: Z12149092
EMDN description: VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Apple Distribution International Limited
Last updated: 15.07.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

AlphaScope™

Class INot specifiedOn the marketDirect markingSingle use

Manufacturer: Gimmi GmbH
Manufacturer SRN: DE-MF-000005445
UDI-DI: 04049047042396
Basic UDI-DI: 4049047ZAO10AFA27DROZJ
Reference: E.8187.21
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:49

Manufacturer products View details

AlphaScope™

Class INot specifiedOn the marketDirect markingSingle use

Manufacturer: Gimmi GmbH
Manufacturer SRN: DE-MF-000005445
UDI-DI: 04049047042433
Basic UDI-DI: 4049047ZAO10AFA27DROZJ
Reference: E.8187.31
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:49

Manufacturer products View details

Otoscopes

Class IMDR 2017/745On the marketActive deviceReusable

Manufacturer: Satellite Industries
Manufacturer SRN: PK-MF-000041675
UDI-DI: G644TOC106003BL1
Basic UDI-DI: ++G644Otoscopes3F
Reference: TOC-106-003BL
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Belgium
Authorised representative: International Business Compendious of Sweden
Last updated: 15.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

Zeno AI

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: WSK Medical
Manufacturer SRN: NL-MF-000010947
UDI-DI: +G739ZENOAI0102X00L
Basic UDI-DI: ++G739ZenoAIYB
Reference: 1
EMDN: Z12149092
EMDN description: VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 15.07.2026 21:32

Manufacturer products View details

uRecorder

URC01

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: UROBOPTICS – TECHNICAL CONSULTING & RESEARCH, LDA
Manufacturer SRN: PT-MF-000026125
UDI-DI: +G550URC0100BEU0K
Basic UDI-DI: ++G550URC015U
Reference: URC0100BEU
EMDN: Z12140480
EMDN description: VESTIBULAR SYSTEM ANALYSIS INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Portugal
Authorised representative: -
Last updated: 15.07.2026 21:21

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Oldenburger Mesprogramme

Oldenburger Messprogramme

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Hörzentrum Oldenburg gGmbH
Manufacturer SRN: DE-MF-000017927
UDI-DI: +G053OMAMDR0B
Basic UDI-DI: ++G053OMAMDRZR
Reference: OMA 2.0.2
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:22

Manufacturer products View details

D-V2C22021Z5

Vesticam2

Class IMDDOn the marketActive device

Manufacturer: Vesticam Pty Ltd
Manufacturer SRN: AU-MF-000047676
UDI-DI: D-V2C22021Z5
Basic UDI-DI: B-V2C22021Z5
Reference: V2C22021
EMDN: Z12140401
EMDN description: VESTIBULAR ASSESSMENT SYSTEMS
First on market country: Norway
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 15.07.2026 13:12

Manufacturer products Authorised representative products Authorised representative actors View details

Stereotaxy Planning System 7.0

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: TATRAMED spol. s r.o.
Manufacturer SRN: SK-MF-000021286
UDI-DI: D-SPSGF
Basic UDI-DI: B-SPSGF
Reference: SPS 7.0
EMDN: Z12140592
EMDN description: STEREOTACTIC ENT SURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Slovakia
Authorised representative: -
Last updated: 15.07.2026 07:00

Manufacturer products View details

Zeno AI

Class IIbNot specifiedOn the marketActive deviceDirect marking

Manufacturer: WSK Medical
Manufacturer SRN: NL-MF-000010947
UDI-DI: +G739ZENOAI0104X00L
Basic UDI-DI: 63057138720299581012RJ
Reference: 1
EMDN: Z12149092
EMDN description: VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 14.07.2026 09:00

Manufacturer products View details

00763000811105

Class IMDR 2017/745On the marketCMR substanceReusable

Manufacturer: Medtronic Navigation Inc.
Manufacturer SRN: US-MF-000023263
UDI-DI: 00763000811105
Basic UDI-DI: 0763000B00027828T
Reference: 9733451
EMDN: Z12140580
EMDN description: STEREOTACTIC ENT SURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 14.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

00763000811099

Class IMDR 2017/745On the marketCMR substanceReusable

Manufacturer: Medtronic Navigation Inc.
Manufacturer SRN: US-MF-000023263
UDI-DI: 00763000811099
Basic UDI-DI: 0763000B00027828T
Reference: 9733450
EMDN: Z12140580
EMDN description: STEREOTACTIC ENT SURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Medtronic B.V.
Last updated: 14.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

DALTE

cabina insonorizada para audiometrías

Class IMDDOn the market

Manufacturer: MNM INGENIERIA SCA
Manufacturer SRN: ES-MF-000024270
UDI-DI: D-ESMF000024270CABINMNMZL
Basic UDI-DI: B-ESMF000024270CABINMNMZL
Reference: Cabina insonorizada
EMDN: Z12149002
EMDN description: AUDIOMETRIC CHAMBERS
First on market country: Spain
Authorised representative: -
Last updated: 13.07.2026 21:02

Manufacturer products View details

DALTE

A 84

Class IMDDOn the market

Manufacturer: MNM INGENIERIA SCA
Manufacturer SRN: ES-MF-000024270
UDI-DI: D-ESMF000024270CABINA01TB
Basic UDI-DI: B-ESMF000024270CABINA01TB
Reference: A 84(84X84X205CM)
EMDN: Z12149002
EMDN description: AUDIOMETRIC CHAMBERS
First on market country: Spain
Authorised representative: -
Last updated: 13.07.2026 21:02

Manufacturer products View details