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

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Single Use Sheath

Class IMDR 2017/745On the marketSingle use

Manufacturer: Shenzhen Besdata Technology Co., Ltd
Manufacturer SRN: CN-MF-000018921
UDI-DI: 06971355353070
Basic UDI-DI: 697135535305694
Reference: SH-BS002
EMDN: Z12149085
EMDN description: VARIOUS ENT INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Single Use Sheath

Class IMDR 2017/745On the marketSingle use

Manufacturer: Shenzhen Besdata Technology Co., Ltd
Manufacturer SRN: CN-MF-000018921
UDI-DI: 06971355353087
Basic UDI-DI: 697135535305694
Reference: SH-BS003
EMDN: Z12149085
EMDN description: VARIOUS ENT INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Single Use Sheath

Class IMDR 2017/745On the marketSingle use

Manufacturer: Shenzhen Besdata Technology Co., Ltd
Manufacturer SRN: CN-MF-000018921
UDI-DI: 06971355353094
Basic UDI-DI: 697135535305694
Reference: SH-BS004
EMDN: Z12149085
EMDN description: VARIOUS ENT INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

00851289007330

DE508

Class IMDR 2017/745On the marketActive device

Manufacturer: Firefly Global
Manufacturer SRN: US-MF-000020015
UDI-DI: 00851289007330
Basic UDI-DI: 0851289007DE508QR
Reference: DE508
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:34

Manufacturer products Authorised representative products Authorised representative actors View details

00851289007101

DE570

Class IMDR 2017/745On the marketActive device

Manufacturer: Firefly Global
Manufacturer SRN: US-MF-000020015
UDI-DI: 00851289007101
Basic UDI-DI: 0851289007DE570QW
Reference: DE570
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:34

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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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

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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

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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

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

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

IP-05M

Insert Earphones

Class IIaMDR 2017/745On the marketActive device

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223143090
Basic UDI-DI: 0426022Earphones-2aQ9
Reference: 100867
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:40

Manufacturer products View details

HP-06

Headphone

Class IIaMDR 2017/745On the marketActive device

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223141652
Basic UDI-DI: 0426022Headphones-2a7R
Reference: 100306-US
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:40

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