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VertiSVV

Class INot specifiedOn the marketDirect marking

Manufacturer: Shanghai ZEHNIT Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000013234
UDI-DI: 06972727560072
Basic UDI-DI: 697272756ZTVS0163
Reference: 007/ZT-SVV-I
EMDN: Z12140401
EMDN description: VESTIBULAR ASSESSMENT SYSTEMS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

VertiGoggles

ZT-VNG-II, ZT-VNG-WLI

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shanghai ZEHNIT Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000013234
UDI-DI: 06972727560041
Basic UDI-DI: 697272756ZTVG0249
Reference: 004
EMDN: Z12140401
EMDN description: VESTIBULAR ASSESSMENT SYSTEMS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

VertiMobile

ZT-VertiMobile-iPhone 6/6s, ZT-VertiMobile-iPhone 7/8, ZT-VertiMobile-iPhone X/Xs, ZT-VertiMobile-iPhone 13/14/15

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shanghai ZEHNIT Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000013234
UDI-DI: 06972727560003
Basic UDI-DI: 697272756ZTVM0155
Reference: 000
EMDN: Z12140401
EMDN description: VESTIBULAR ASSESSMENT SYSTEMS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

06972545091000

HS-OT10,HS-OT10A,HS-OT10B,HS-OT10C, HS-OT10D,HS-OT10E,HS-OT10F, HS-OT10G,HS-OT10H,HS-OT10I, HS-OT10J,HS-OT10K,HS-OT10L, HS-OT10L-C,HS-OT10L-C2,HS-OT10M, HS-OT10N, HS-OT10P,HS-OT10Q, HS-OT10R,HS-OT10S,HS-OT10T, HS-OT10U,HS-OT10W,HS-OT10X, HS-OT10Y,HS-OT10Z

Class IMDR 2017/745On the marketActive device

Manufacturer: Zhejiang Honsun Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000039480
UDI-DI: 06972545091000
Basic UDI-DI: 697254509OTOSCOPETY
Reference: HS-OT10
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 12:59

Manufacturer products Authorised representative products Authorised representative actors View details

06971919461708

OS801, OS802, OS803, OS804, OS805, OS806, OS807, OS808, OS809, OS810, OS811, OS812, OS813, OS814, OS816, OS817, OS818, OS819, OS820, OS821, OS826, OS828, OS830

Class IMDR 2017/745On the market

Manufacturer: Ningbo Albert Novosino Co.,Ltd.
Manufacturer SRN: CN-MF-000008571
UDI-DI: 06971919461708
Basic UDI-DI: 697191946EO4R
Reference: OS811
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

06975633110010

EJ2001, EJ2001A, EJ2002, EJ2003, EJ2003A, EJ2004, EJ2005, EJ2006, EJ2007, EJ2008, EJ2009, EJ2010, EJ2011, EJ2012, EJ2013, EJ2014, EJ2015, EJ2016, EJ2017, EJ2018, EJ2019, EJ2020, EJ2021, EJ2022, EJ2023, EJ2024, EJ2025, EJ2026

Class IMDR 2017/745On the marketReusable

Manufacturer: Tonglu Sike Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000051027
UDI-DI: 06975633110010
Basic UDI-DI: 697058187EJ001EQ
Reference: EJ2001
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: endodoctor GmbH
Last updated: 02.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

05713315000768

1066 Astera2 Accessories - Software

Class IIaMDR 2017/745On the market

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315000768
Basic UDI-DI: 5713315NA000765R
Reference: 8-49-90600
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:50

Manufacturer products View details

RadioEar IP30

IP30

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: DGS Diagnostics A/S
Manufacturer SRN: DK-MF-000020570
UDI-DI: 05711117243871
Basic UDI-DI: 5711117_P-0000129_RB
Reference: 8601097
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

DD65v2

Class IIaMDR 2017/745On the marketActive device

Manufacturer: DGS Diagnostics A/S
Manufacturer SRN: DK-MF-000020570
UDI-DI: 05711117228779
Basic UDI-DI: 5711117_P-0000506_RL
Reference: 8520327
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

DD450

Class IIaMDR 2017/745On the marketActive device

Manufacturer: DGS Diagnostics A/S
Manufacturer SRN: DK-MF-000020570
UDI-DI: 05711117228717
Basic UDI-DI: 5711117_P-0000505_RH
Reference: 8520308
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

Sanibel EARturtle Universal Box of 36 kits w/tab electrodes

EARturtle with electrodes

Class IMDR 2017/745On the market

Manufacturer: DGS Diagnostics A/S
Manufacturer SRN: DK-PR-000031217
UDI-DI: 05711117230802
Basic UDI-DI: 5711117_P-0000556_02_YN
Reference: 8537209
EMDN: Z12140385
EMDN description: EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 04:47

Manufacturer products View details

Sanibel EARturtle Universal

EARturtle

Class IMDR 2017/745On the market

Manufacturer: DGS Diagnostics A/S
Manufacturer SRN: DK-MF-000020570
UDI-DI: 05711117230796
Basic UDI-DI: 5711117_P-0000403_R4
Reference: 8537206
EMDN: Z12140385
EMDN description: EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:47

Manufacturer products View details

CIR insert earphone

CIR

Class IIaMDR 2017/745On the marketActive device

Manufacturer: DGS Diagnostics A/S
Manufacturer SRN: DK-MF-000020570
UDI-DI: 05711117225952
Basic UDI-DI: 5711117_P-0000507_RP
Reference: 8528954
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

DD45

Class IIaMDR 2017/745On the marketActive device

Manufacturer: DGS Diagnostics A/S
Manufacturer SRN: DK-MF-000020570
UDI-DI: 05711117221671
Basic UDI-DI: 5711117_P-0000504_RE
Reference: 8010879
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

B-81

Class IIaMDR 2017/745On the marketActive device

Manufacturer: DGS Diagnostics A/S
Manufacturer SRN: DK-MF-000020570
UDI-DI: 05711117219586
Basic UDI-DI: 5711117_P-0000503_RB
Reference: 8104119
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

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

Examination cabinet

ENTC0102

Class IMDR 2017/745On the marketDirect marking

Manufacturer: ΠΑΠΠΑΣ Ν. & ΣΙΑ ΟΕ
Manufacturer SRN: GR-MF-000016242
UDI-DI: 05214002308087
Basic UDI-DI: 5214002308ENTC0102VZ
Reference: ENTC0102
EMDN: Z121402
EMDN description: ENT TREATMENT UNITS
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 03:11

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