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01.08.2026 01:12

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Switch Box Assembly A‑B

7190-2500

Class IMDR 2017/745On the market

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333231553
Basic UDI-DI: 496133303A7190VA
Reference: 7190‑2500
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:28

Manufacturer products Authorised representative products Authorised representative actors View details

Adult Small Disposable Masks

6625

Class IMDR 2017/745On the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333231041
Basic UDI-DI: 496133303A6625VH
Reference: 6625
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:28

Manufacturer products Authorised representative products Authorised representative actors View details

Pediatric Disposable Masks

6615

Class IMDR 2017/745On the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333231034
Basic UDI-DI: 496133303A6615VE
Reference: 6615
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cardboard Tubes (Disposable)

6610

Class IMDR 2017/745On the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333230105
Basic UDI-DI: 496133303A6610V4
Reference: 6610
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:28

Manufacturer products Authorised representative products Authorised representative actors View details

Pediatric Mask with Adaptor

6606

Class IMDR 2017/745On the market

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333230099
Basic UDI-DI: 496133303A6606VD
Reference: 6606
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:28

Manufacturer products Authorised representative products Authorised representative actors View details

Adult Face Mask, Extra

6602

Class IMDR 2017/745On the market

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333230082
Basic UDI-DI: 496133303A6602V5
Reference: 6602
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:27

Manufacturer products Authorised representative products Authorised representative actors View details

Flowhead, Extra

6601

Class IMDR 2017/745On the market

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333230075
Basic UDI-DI: 496133303A6601V3
Reference: 6601
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:27

Manufacturer products Authorised representative products Authorised representative actors View details

Intra‑Oral Tubes

6611

Class IMDR 2017/745On the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333229918
Basic UDI-DI: 496133303A6611V6
Reference: 6611
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 31.07.2026 07:27

Manufacturer products Authorised representative products Authorised representative actors View details

04745010564062

McCormick rattle

Class IMDR 2017/745On the market

Manufacturer: 1M4 OÜ
Manufacturer SRN: EE-MF-000040367
UDI-DI: 04745010564062
Basic UDI-DI: 474501056410006BC
Reference: 10006.00
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Estonia
Authorised representative: -
Last updated: 31.07.2026 06:55

Manufacturer products View details

04260381960164

Disposable Ear Funnels

Class IMDR 2017/745On the marketSingle use

Manufacturer: Luxamed GmbH & Co. KG
Manufacturer SRN: DE-MF-000006437
UDI-DI: 04260381960164
Basic UDI-DI: 426038196OhrtrichterXE
Reference: A5.101.144
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:54

Manufacturer products View details

04260381960010

LuxaScope Auris LED

Class IMDR 2017/745On the marketActive device

Manufacturer: Luxamed GmbH & Co. KG
Manufacturer SRN: DE-MF-000006437
UDI-DI: 04260381960010
Basic UDI-DI: 426038196OtoskopYN
Reference: A1.416.114
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:54

Manufacturer products View details

Otoscopes

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: STEMA Medizintechnik GmbH
Manufacturer SRN: DE-MF-000005523
UDI-DI: 04049203060790
Basic UDI-DI: 40492030000175BZ
Reference: LA-000-001
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 22:59

Manufacturer products View details

AlphaScope™

Laryngoscope, Otoscope and Accessories

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Gimmi GmbH
Manufacturer SRN: DE-MF-000005445
UDI-DI: 04049047042358
Basic UDI-DI: 4049047ZAO10AFA27DROZJ
Reference: E.8187.11
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 22:52

Manufacturer products View details

OTOSCOPES

Otoscope

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Henke-Sass, Wolf GmbH
Manufacturer SRN: DE-MF-000005531
UDI-DI: 04035873070719
Basic UDI-DI: 4035873120101029S
Reference: 8300058412
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 22:28

Manufacturer products 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: 30.07.2026 21:54

Manufacturer products View details

Welch Allyn

901001

Class IMDR 2017/745On the market

Manufacturer: Welch Allyn, Inc.
Manufacturer SRN: US-MF-000013394
UDI-DI: 00732094011944
Basic UDI-DI: 0732094GMN901001EG
Reference: 24400-U
EMDN: Z12149085
EMDN description: VARIOUS ENT INSTRUMENTS - CONSUMABLES
First on market country: Ireland
Authorised representative: Welch Allyn Limited
Last updated: 30.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

QScreen

PM1610

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223145766
Basic UDI-DI: 0426022QScreen-2aDM
Reference: 101199
EMDN: Z12149001
EMDN description: OTOACOUSTIC EMISSIONS EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:40

Manufacturer products View details

ET-S01

Ear Tips for Ear Probes

Class IMDR 2017/745On the marketSingle use

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223144806
Basic UDI-DI: 0426022Probes-16B
Reference: 100029-100
EMDN: Z12149005
EMDN description: IMPEDANCE METERS FOR THE AUDITORY SYSTEM
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:40

Manufacturer products View details

nanoTymp

TU100948

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223143694
Basic UDI-DI: 0426022TY-MU-2aNP
Reference: 100948
EMDN: Z12149005
EMDN description: IMPEDANCE METERS FOR THE AUDITORY SYSTEM
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:40

Manufacturer products View details

TEOAE probe

100120

Class IIaMDR 2017/745On the marketActive device

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223140044
Basic UDI-DI: 0426022Probes-2aTM
Reference: 100120
EMDN: Z12149001
EMDN description: OTOACOUSTIC EMISSIONS EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:40

Manufacturer products View details