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Diagnostix™

Class IMDR 2017/745On the marketActive device

Manufacturer: American Diagnostic Corporation
Manufacturer SRN: US-MF-000021544
UDI-DI: 00634782083199
Basic UDI-DI: 063478251115211DK
Reference: 5111NL
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: -
Authorised representative: S.C. Cattus S.R.L.
Last updated: 22.06.2026 16:25

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostix™

Class IMDR 2017/745On the marketActive device

Manufacturer: American Diagnostic Corporation
Manufacturer SRN: US-MF-000021544
UDI-DI: 00634782087050
Basic UDI-DI: 063478251115211DK
Reference: 5120NLV-02
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: -
Authorised representative: S.C. Cattus S.R.L.
Last updated: 22.06.2026 16:25

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostix™

Class IMDR 2017/745On the market

Manufacturer: American Diagnostic Corporation
Manufacturer SRN: US-MF-000021544
UDI-DI: 00634782091491
Basic UDI-DI: 063478256105680H4
Reference: 5680L-36L
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: -
Authorised representative: S.C. Cattus S.R.L.
Last updated: 22.06.2026 16:25

Manufacturer products Authorised representative products Authorised representative actors View details

Screening Tubes

Class INot specifiedOn the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333230112
Basic UDI-DI: 496133303A6611V6
Reference: 6612
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

Airflow Head‑Mask Couplers

Class INot specifiedOn the market

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333230129
Basic UDI-DI: 496133303A6610V4
Reference: 6613
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

Pressure Port Tubes

Class INot specifiedOn the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333230136
Basic UDI-DI: 496133303A6611V6
Reference: 6614
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

Flowhead Tubes

Class INot specifiedOn the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333230501
Basic UDI-DI: 496133303A6611V6
Reference: 7189‑4200
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

Adult Small Disposable Masks

Class INot specifiedOn the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333231058
Basic UDI-DI: 496133303A6625VH
Reference: 6635
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

Adult Large Disposable Masks

Class INot specifiedOn the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333231065
Basic UDI-DI: 496133303A6625VH
Reference: 6645
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

Phonatory Aerodynamic System (PAS)

Class INot specifiedOn the marketDirect marking

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333247424
Basic UDI-DI: 496133303660026
Reference: 6600
EMDN: Z12149010
EMDN description: ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

PAS Tubing Kit

Class INot specifiedOn the marketSingle use

Manufacturer: PENTAX of America Inc.
Manufacturer SRN: US-MF-000008135
UDI-DI: 04961333255986
Basic UDI-DI: 496133303A6611V6
Reference: 6650
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: PENTAX Europe GmbH
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

Otoscope