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Otodynamics

LTC-ST+ABR

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: OTODYNAMICS LTD
Manufacturer SRN: GB-MF-000018964
UDI-DI: 05060396170010
Basic UDI-DI: B-05060396170010
Reference: LTC-ST+ABR
EMDN: Z12140302
EMDN description: EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Otodynamics

LTC-ST

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: OTODYNAMICS LTD
Manufacturer SRN: GB-MF-000018964
UDI-DI: 05060396170003
Basic UDI-DI: B-05060396170003
Reference: LTC-ST
EMDN: Z12149001
EMDN description: OTOACOUSTIC EMISSIONS EQUIPMENT
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

MADSEN Capella2

M011130

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Intelligent Hearing Systems Corp.
Manufacturer SRN: US-MF-000011473
UDI-DI: 00817020029924
Basic UDI-DI: B-00817020029924
Reference: 8-04-15320
EMDN: Z12149001
EMDN description: OTOACOUSTIC EMISSIONS EQUIPMENT
First on market country: Denmark
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

03760253450324

FF1075

Class IMDR 2017/745On the marketSingle use

Manufacturer: FIM Medical
Manufacturer SRN: FR-MF-000017090
UDI-DI: 03760253450324
Basic UDI-DI: 376025345FF1075TU
Reference: FF1075
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 01.08.2026 04:10

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Oldenburger Mesprogramme

Oldenburger Messprogramme

Class IIaMDDNo longer on the marketActive device

Manufacturer: Hörzentrum Oldenburg gGmbH
Manufacturer SRN: DE-MF-000017927
UDI-DI: *+G053OMA0Z*
Basic UDI-DI: B-*+G053OMA0Z*
Reference: OEM070002
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 01.08.2026 01:38

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OPTIMUS ELITE

Workstation type C

Class IIaMDR 2017/745On the marketActive device

Manufacturer: OPTOMIC ESPAÑA S.A
Manufacturer SRN: ES-MF-000003235
UDI-DI: 08436041581178
Basic UDI-DI: 84360415814353F
Reference: 67633056
EMDN: Z121402
EMDN description: ENT TREATMENT UNITS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:50

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OPTIMUS EXPERT

Workstaion type D

Class IIaMDR 2017/745On the marketActive device

Manufacturer: OPTOMIC ESPAÑA S.A
Manufacturer SRN: ES-MF-000003235
UDI-DI: 08436041581161
Basic UDI-DI: 84360415815363N
Reference: 67633049
EMDN: Z121402
EMDN description: ENT TREATMENT UNITS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:50

Manufacturer products View details

OTOSMART PLUS

Workstaion type B

Class IIaMDR 2017/745On the marketActive device

Manufacturer: OPTOMIC ESPAÑA S.A
Manufacturer SRN: ES-MF-000003235
UDI-DI: 08436041581130
Basic UDI-DI: 843604158133438
Reference: 67633028
EMDN: Z121402
EMDN description: ENT TREATMENT UNITS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:49

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OPTIMUS

Workstation type A

Class IIaMDR 2017/745On the marketActive device

Manufacturer: OPTOMIC ESPAÑA S.A
Manufacturer SRN: ES-MF-000003235
UDI-DI: 08436041581116
Basic UDI-DI: 84360415812332Z
Reference: 67633007
EMDN: Z121402
EMDN description: ENT TREATMENT UNITS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:49

Manufacturer products View details

Sistema Sibelsound DUO A

Sistema Sibelsound DUO

Class IIaMDR 2017/745On the market

Manufacturer: SIBEL SAU
Manufacturer SRN: ES-PR-000052577
UDI-DI: 08436035524303
Basic UDI-DI: 843603552AAUY00201TU
Reference: 09132-S
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 22:44

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Sistema Sibelsound 400 A

Sistema Sibelsound 400

Class IIaMDR 2017/745On the market

Manufacturer: SIBEL SAU
Manufacturer SRN: ES-PR-000052577
UDI-DI: 08436035524242
Basic UDI-DI: 843603552AAUY00101TP
Reference: 01378-S
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 22:44

Manufacturer products View details

Sibbo Loupe

Loupe

Class IMDR 2017/745On the market

Manufacturer: Sibbo Medical Devices Oy
Manufacturer SRN: FI-MF-000035896
UDI-DI: 06429811118119
Basic UDI-DI: 6429811118LoupeQQ
Reference: SL-001-H
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:46

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Zeno AI

Class IIbMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: WSK Medical
Manufacturer SRN: NL-MF-000010947
UDI-DI: +G739ZENOAI0103X00L
Basic UDI-DI: 63057138720299581012RJ
Reference: 1
EMDN: Z12149092
EMDN description: VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 17:24

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Elysium orrmosó só 2,7g - 30 db

Orrmosó só

Class IMDR 2017/745On the market

Manufacturer: Elysium Laboratories Kft.
Manufacturer SRN: HU-MF-000039543
UDI-DI: 05999862705404
Basic UDI-DI: 5999862705SLT01V6
Reference: 10022
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

Oscilla® A50 w. H210A headset & B71

ATM4

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Oscilla A/S
Manufacturer SRN: DK-MF-000002784
UDI-DI: 05745000311064
Basic UDI-DI: 5745000311ATM4TW
Reference: 1234
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Austria
Authorised representative: -
Last updated: 31.07.2026 12:39

Manufacturer products View details

05713315009969

Bone Conductor

Class IIaMDR 2017/745On the market

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315009969
Basic UDI-DI: 5713315NA001445H
Reference: 041545
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:13

Manufacturer products View details

Foam Ear Tips

Foam Eartip

Class IMDR 2017/745On the marketSingle use

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315009310
Basic UDI-DI: 5713315NA001075B
Reference: 80A4821000
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:13

Manufacturer products View details

1081 Madsen A450

Madsen A450

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315007224
Basic UDI-DI: 5713315NA0004258
Reference: 8-04-14567
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:13

Manufacturer products View details

Aircal

8-04-13321

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315006456
Basic UDI-DI: 5713315NA0009863
Reference: 8-04-13321
EMDN: Z12140480
EMDN description: VESTIBULAR SYSTEM ANALYSIS INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:13

Manufacturer products View details

AURICAL AUD

1081 Aurical Aud

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315006050
Basic UDI-DI: 5713315NA000455E
Reference: 8-04-14590
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:13

Manufacturer products View details