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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

Zeno AI

Class IIbNot specifiedOn the marketActive deviceDirect marking

Manufacturer: WSK Medical
Manufacturer SRN: NL-MF-000010947
UDI-DI: +G739ZENOAI0104X00L
Basic UDI-DI: 63057138720299581012RJ
Reference: 1
EMDN: Z12149092
EMDN description: VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: -
Last updated: 14.07.2026 09:00

Manufacturer products View details

DALTE

cabina insonorizada para audiometrías

Class IMDDOn the market

Manufacturer: MNM INGENIERIA SCA
Manufacturer SRN: ES-MF-000024270
UDI-DI: D-ESMF000024270CABINMNMZL
Basic UDI-DI: B-ESMF000024270CABINMNMZL
Reference: Cabina insonorizada
EMDN: Z12149002
EMDN description: AUDIOMETRIC CHAMBERS
First on market country: Spain
Authorised representative: -
Last updated: 13.07.2026 21:02

Manufacturer products View details

DALTE

A 84

Class IMDDOn the market

Manufacturer: MNM INGENIERIA SCA
Manufacturer SRN: ES-MF-000024270
UDI-DI: D-ESMF000024270CABINA01TB
Basic UDI-DI: B-ESMF000024270CABINA01TB
Reference: A 84(84X84X205CM)
EMDN: Z12149002
EMDN description: AUDIOMETRIC CHAMBERS
First on market country: Spain
Authorised representative: -
Last updated: 13.07.2026 21:02

Manufacturer products View details

Surgify Safety Burr

100-54-TL

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Surgify Medical Oy
Manufacturer SRN: FI-MF-000017137
UDI-DI: D-100-54-TLHC
Basic UDI-DI: B-100-54-TLHC
Reference: 100-54-TL
EMDN: Z12149085
EMDN description: VARIOUS ENT INSTRUMENTS - CONSUMABLES
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 00:33

Manufacturer products View details

Sanibel REM Probe Tubes

Class IMDR 2017/745On the market

Manufacturer: DGS Diagnostics A/S
Manufacturer SRN: DK-MF-000020570
UDI-DI: 05711117244335
Basic UDI-DI: 5711117_P-0000498_SY
Reference: 8602724
EMDN: Z12149085
EMDN description: VARIOUS ENT INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 10.07.2026 22:49

Manufacturer products View details

Sanibel REM Probe Tubes

Class IMDR 2017/745On the market

Manufacturer: DGS Diagnostics A/S
Manufacturer SRN: DK-MF-000020570
UDI-DI: 05711117227574
Basic UDI-DI: 5711117_P-0000498_SY
Reference: 8533303
EMDN: Z12149085
EMDN description: VARIOUS ENT INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 10.07.2026 22:49

Manufacturer products View details

Sanibel REM Probe Tubes

Class IMDR 2017/745On the market

Manufacturer: DGS Diagnostics A/S
Manufacturer SRN: DK-MF-000020570
UDI-DI: 05711117227581
Basic UDI-DI: 5711117_P-0000498_SY
Reference: 8533304
EMDN: Z12149085
EMDN description: VARIOUS ENT INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 10.07.2026 22:49

Manufacturer products View details

Sanibel Ear tip