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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

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

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

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

Manufacturer products View details

ET-12

Ear Tips for Ear Probes

Class IMDR 2017/745On the marketSingle use

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223141287
Basic UDI-DI: 0426022Probes-16B
Reference: 100126-50
EMDN: Z12149001
EMDN description: OTOACOUSTIC EMISSIONS EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:39

Manufacturer products View details

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

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

Manufacturer products View details

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

Manufacturer products View details