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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

Sentiero Advanced

SOH100098

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223142444
Basic UDI-DI: 0426022Sentiero-2aHJ
Reference: 100360
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

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

EC-1

EC-02

Class IMDR 2017/745On the market

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223141393
Basic UDI-DI: 0426022ElectrodeCable-13U
Reference: 100077
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

ECC-1

ECC

Class IIaMDR 2017/745On the marketActive device

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223141386
Basic UDI-DI: 0426022ECC-2a5Z
Reference: 100127
EMDN: Z12140302
EMDN description: EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:39

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

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

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

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

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