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B71

Class IIaMDR 2017/745On the marketActive device

Manufacturer: DGS Diagnostics A/S
Manufacturer SRN: DK-MF-000020570
UDI-DI: 05711117192056
Basic UDI-DI: 5711117_P-0000502_R8
Reference: 8102514
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:47

Manufacturer products View details

05060485270775

Otoscope

Class IMDR 2017/745On the marketActive device

Manufacturer: GM Instruments Ltd
Manufacturer SRN: GB-MF-000020565
UDI-DI: 05060485270775
Basic UDI-DI: 506048527GMACCOTOQ2
Reference: AC300-OTS
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.07.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

05060485270041

NV Rhinospirometer

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GM Instruments Ltd
Manufacturer SRN: GB-MF-000020565
UDI-DI: 05060485270041
Basic UDI-DI: 506048527GMNVRHIN52
Reference: NV1-PC
EMDN: Z12149008
EMDN description: RHINOANEMOMETERS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.07.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

A1 ACOUSTIC RHINOMETER CLINICAL

A1 Acoustic Rhinometer

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GM Instruments Ltd
Manufacturer SRN: GB-MF-000020565
UDI-DI: 05060485270027
Basic UDI-DI: 506048527GMA1ACOUFS
Reference: A1-C
EMDN: Z12149009
EMDN description: RHINOMETERS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.07.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

DISPOSABLE SPECULA 3.5MM (PK OF 500)

OTOSCOPE SPECULA

Class IMDR 2017/745On the market

Manufacturer: Keeler Ltd
Manufacturer SRN: GB-MF-000009031
UDI-DI: 05055272701853
Basic UDI-DI: 50552727SPECULATV
Reference: 1501-P-5170
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Croatia
Authorised representative: Keeler Europe Distribution, S.L.
Last updated: 02.07.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

Fibre Diagnostic Otoscope

CK-938

Class IMDR 2017/745On the marketActive device

Manufacturer: CHIN KOU MEDICAL INSTRUMENT CO., LTD.
Manufacturer SRN: TW-MF-000042725
UDI-DI: 04719890209382
Basic UDI-DI: 471989020OSCK93XUE
Reference: CK-938
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Bulgaria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Fibre Diagnostic Otoscope

Class IMDR 2017/745On the marketActive device

Manufacturer: CHIN KOU MEDICAL INSTRUMENT CO., LTD.
Manufacturer SRN: TW-MF-000042725
UDI-DI: 04719890209399
Basic UDI-DI: 471989020OSCK93XUE
Reference: CK-939
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Fibre Diagnostic Otoscope

Class IMDR 2017/745On the marketActive device

Manufacturer: CHIN KOU MEDICAL INSTRUMENT CO., LTD.
Manufacturer SRN: TW-MF-000042725
UDI-DI: 04719890209405
Basic UDI-DI: 471989020OSCK93XUE
Reference: CK-938A
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Fibre Diagnostic Otoscope

Class IMDR 2017/745On the marketActive device

Manufacturer: CHIN KOU MEDICAL INSTRUMENT CO., LTD.
Manufacturer SRN: TW-MF-000042725
UDI-DI: 04719890209412
Basic UDI-DI: 471989020OSCK93XUE
Reference: CK-939A
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Radiantlite

Class IMDR 2017/745On the marketActive device

Manufacturer: CHIN KOU MEDICAL INSTRUMENT CO., LTD.
Manufacturer SRN: TW-MF-000042725
UDI-DI: 04719890209429
Basic UDI-DI: 471989020OSCK93XUE
Reference: CK-S908
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

04048551196342

Probes/Bougies/Dilators

Class IMDR 2017/745On the market

Manufacturer: KARL STORZ SE & Co. KG
Manufacturer SRN: DE-MF-000005723
UDI-DI: 04048551196342
Basic UDI-DI: 4048551001441TM
Reference: 745708
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:26

Manufacturer products View details

04048551196502

Probes/Bougies/Dilators

Class IMDR 2017/745On the market

Manufacturer: KARL STORZ SE & Co. KG
Manufacturer SRN: DE-MF-000005723
UDI-DI: 04048551196502
Basic UDI-DI: 4048551001447TZ
Reference: 745847
EMDN: Z12149080
EMDN description: VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:26

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: 04035873011422
Basic UDI-DI: 4035873120101029S
Reference: 89550240
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 17:23

Manufacturer products View details

iAudiogram®

AudioPod®

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: MY MEDICAL ASSISTANT
Manufacturer SRN: FR-MF-000019847
UDI-DI: 03770025150000
Basic UDI-DI: 3770025150LOGAUDIOPODV7
Reference: iAudiogram®
EMDN: Z12149092
EMDN description: VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:06

Manufacturer products View details

03701126700030

Spéculum auriculaire à usage unique

Class IMDR 2017/745On the marketSingle use

Manufacturer: COMED SAS
Manufacturer SRN: FR-MF-000000151
UDI-DI: 03701126700030
Basic UDI-DI: 37011267247XXXXTS
Reference: 24 701 25
EMDN: Z12149085
EMDN description: VARIOUS ENT INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 14:40

Manufacturer products View details

Otoscope

Class IMDR 2017/745On the market

Manufacturer: HONSUN (NANTONG) Co., Ltd.
Manufacturer SRN: CN-MF-000009428
UDI-DI: 06970384252767
Basic UDI-DI: 697038425OTSTV
Reference: HS-OT10S
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Otoscope

Class IMDR 2017/745On the market

Manufacturer: HONSUN (NANTONG) Co., Ltd.
Manufacturer SRN: CN-MF-000009428
UDI-DI: 06970384250008
Basic UDI-DI: 697038425OTSTV
Reference: HS-OT10G
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 02:15

Manufacturer products Authorised representative products Authorised representative actors View details

OTOSCOPIO VETERINARIO CON ILLUMINAZIONE LED

Class IMDR 2017/745On the market

Manufacturer: AIESI HOSPITAL SERVICE S.a.s. di PIANTADOSI VALERIO E C
Manufacturer SRN: IT-MF-000032617
UDI-DI: 18052283200980
Basic UDI-DI: 805228320Z12149006WD
Reference: AHS792
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:11

Manufacturer products View details

Otoscope

ER02

Class IMDR 2017/745On the market

Manufacturer: Tianjin Bolang Science-Technology Development Co.,Ltd.
Manufacturer SRN: CN-MF-000008431
UDI-DI: 06947752802626
Basic UDI-DI: 69477528ERJT
Reference: ER34.140.WA
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 02:02

Manufacturer products Authorised representative products Authorised representative actors View details

Otoscope

ER02

Class IMDR 2017/745On the market

Manufacturer: Tianjin Bolang Science-Technology Development Co.,Ltd.
Manufacturer SRN: CN-MF-000008431
UDI-DI: 06947752802619
Basic UDI-DI: 69477528ERJT
Reference: ER33.140.WA
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 02:02

Manufacturer products Authorised representative products Authorised representative actors View details