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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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00851289007064

DE500

Class IMDR 2017/745On the marketActive device

Manufacturer: Firefly Global
Manufacturer SRN: US-MF-000020015
UDI-DI: 00851289007064
Basic UDI-DI: 0851289007DE500Q9
Reference: DE500
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

00851289007019

DE550

Class IMDR 2017/745On the marketActive device

Manufacturer: Firefly Global
Manufacturer SRN: US-MF-000020015
UDI-DI: 00851289007019
Basic UDI-DI: 0851289007DE550QQ
Reference: DE550
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

hearOAE

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: hearX SA (Pty) Ltd
Manufacturer SRN: ZA-MF-000031452
UDI-DI: 00850022464621
Basic UDI-DI: 0850022464HearOAETC
Reference: None
EMDN: Z12149001
EMDN description: OTOACOUSTIC EMISSIONS EQUIPMENT
First on market country: Sweden
Authorised representative: Advena Limited
Last updated: 16.07.2026 06:19

Manufacturer products Authorised representative products Authorised representative actors View details

00850017250079

Type 1001

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Bertec Corporation
Manufacturer SRN: US-MF-000008643
UDI-DI: 00850017250079
Basic UDI-DI: 0850017250TYPE1001K3
Reference: 97P-0036
EMDN: Z12140404
EMDN description: POSTUROGRAPHY SYSTEMS
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details

00850017250017

Type 1002

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Bertec Corporation
Manufacturer SRN: US-MF-000008643
UDI-DI: 00850017250017
Basic UDI-DI: 0850017250TYPE1002K5
Reference: Type 1002-06/97P-0077
EMDN: Z12140404
EMDN description: POSTUROGRAPHY SYSTEMS
First on market country: Poland
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details

00850017250000

Type 1003

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Bertec Corporation
Manufacturer SRN: US-MF-000008643
UDI-DI: 00850017250000
Basic UDI-DI: 0850017250TYPE1003K7
Reference: 97P-0037
EMDN: Z12140401
EMDN description: VESTIBULAR ASSESSMENT SYSTEMS
First on market country: Poland
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details

Pro Fit Fitting Software

Class IIaMDR 2017/745On the market

Manufacturer: Starkey Laboratories Inc.
Manufacturer SRN: US-MF-000014382
UDI-DI: 00842318190376
Basic UDI-DI: 0842318160516UN
Reference: 60516-000
EMDN: Z12149092
EMDN description: VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Starkey Laboratories (Germany) GmbH
Last updated: 16.07.2026 05:19

Manufacturer products Authorised representative products Authorised representative actors View details

My Starkey Mobile App

Class IIaMDR 2017/745On the market

Manufacturer: Starkey Laboratories Inc.
Manufacturer SRN: US-MF-000014382
UDI-DI: 00842318131171
Basic UDI-DI: 0842318160945VH
Reference: My Starkey
EMDN: Z12149092
EMDN description: VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Starkey Laboratories (Germany) GmbH
Last updated: 16.07.2026 05:18

Manufacturer products Authorised representative products Authorised representative actors View details

Thrive Software

Thrive Software Application

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Starkey Laboratories Inc.
Manufacturer SRN: US-MF-000014382
UDI-DI: 00842318130808
Basic UDI-DI: 0842318161475V8
Reference: N/A
EMDN: Z12149092
EMDN description: VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Starkey Laboratories (Germany) GmbH
Last updated: 16.07.2026 05:18

Manufacturer products Authorised representative products Authorised representative actors View details

Starkey Inspire X Fitting Software

Inspire Fitting Software

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Starkey Laboratories Inc.
Manufacturer SRN: US-MF-000014382
UDI-DI: 00842318117175
Basic UDI-DI: 0842318160211TV
Reference: 60211
EMDN: Z12149092
EMDN description: VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Starkey Laboratories (Germany) GmbH
Last updated: 16.07.2026 05:18

Manufacturer products Authorised representative products Authorised representative actors View details

00821925027787

Class INot specifiedOn the market

Manufacturer: Gyrus ACMI, Inc.
Manufacturer SRN: US-MF-000034237
UDI-DI: 00821925027787
Basic UDI-DI: 0821925000215B
Reference: MDFS100
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Olympus Europa SE & Co. KG
Last updated: 16.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

USB Jr Duet

M010300

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Intelligent Hearing Systems Corp.
Manufacturer SRN: US-MF-000011473
UDI-DI: 00817020020075
Basic UDI-DI: 08172002M010300EP
Reference: M010300
EMDN: Z12149001
EMDN description: OTOACOUSTIC EMISSIONS EQUIPMENT
First on market country: Spain
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 04:26

Manufacturer products Authorised representative products Authorised representative actors View details

00763000811082

EM ENT Suction

Class IMDR 2017/745On the marketCMR substanceReusable

Manufacturer: Medtronic Navigation Inc.
Manufacturer SRN: US-MF-000023263
UDI-DI: 00763000811082
Basic UDI-DI: 0763000B00027828T
Reference: 9733449
EMDN: Z12140580
EMDN description: STEREOTACTIC ENT SURGERY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Medtronic B.V.
Last updated: 16.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable Ear Speculum 2,5 mm

Ear Speculum

Class IMDR 2017/745On the marketSingle use

Manufacturer: Hammarplast Medical AB
Manufacturer SRN: SE-MF-000009420
UDI-DI: 07340077905000
Basic UDI-DI: 0734007791003TP
Reference: 31110
EMDN: Z12149085
EMDN description: VARIOUS ENT INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 16.07.2026 03:01

Manufacturer products View details

BALANCE SYSTEM SD 230V

Balance System

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Biodex Medical Systems
Manufacturer SRN: US-MF-000028834
UDI-DI: 00718175000045
Basic UDI-DI: 07181752095A
Reference: 950-441
EMDN: Z12140404
EMDN description: POSTUROGRAPHY SYSTEMS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 02:43

Manufacturer products Authorised representative products Authorised representative actors View details

OtoClear Tips

Class IMDR 2017/745On the marketSingle use

Manufacturer: Bionix LLC
Manufacturer SRN: US-MF-000020408
UDI-DI: 00714646000705
Basic UDI-DI: 0714646OtoClearTipRW
Reference: 7200ST
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 02:43

Manufacturer products Authorised representative products Authorised representative actors View details

Adstation™

Throat Illuminator and parts

Class IMDR 2017/745On the market

Manufacturer: American Diagnostic Corporation
Manufacturer SRN: US-MF-000021544
UDI-DI: 00634782079864
Basic UDI-DI: 063478256105680H4
Reference: 5610L-36L
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Romania
Authorised representative: S.C. Cattus S.R.L.
Last updated: 16.07.2026 01:06

Manufacturer products Authorised representative products Authorised representative actors View details

Proscope™

Otoscope and parts

Class IMDR 2017/745On the marketActive device

Manufacturer: American Diagnostic Corporation
Manufacturer SRN: US-MF-000021544
UDI-DI: 00634782035341
Basic UDI-DI: 063478251115211DK
Reference: 5211
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Romania
Authorised representative: S.C. Cattus S.R.L.
Last updated: 16.07.2026 01:06

Manufacturer products Authorised representative products Authorised representative actors View details

ABR-S

ABR-L

Class IMDR 2017/745On the market

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223145483
Basic UDI-DI: 0426022ALGO7i-1EC
Reference: 101001
EMDN: Z12140380
EMDN description: EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:40

Manufacturer products View details

ATA-S

A7i-101049

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223145469
Basic UDI-DI: 0426022ALGO7i-2aLU
Reference: 101003
EMDN: Z12140302
EMDN description: EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:40

Manufacturer products View details