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ClearEar Extra (Sodium Bicarbonate Ear Drops)

Sodium Bicarbonate Ear Drops

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Zuche Pharmaceuticals Pvt Ltd
Manufacturer SRN: IN-MF-000010593
UDI-DI: 08906167530041
Basic UDI-DI: 890616753SBDRQ
Reference: SBD
EMDN: Q03040299
EMDN description: EAR IRRIGATION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 00:27

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Osseous

ENT Instruments

Class IMDR 2017/745On the marketReusable

Manufacturer: EON MEDITECH PVT. LTD
Manufacturer SRN: IN-MF-000014457
UDI-DI: 08906039318081
Basic UDI-DI: 89044287ESFM
Reference: EI0951
EMDN: Q030499
EMDN description: OTOLOGY DEVICES - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 00:14

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Paramount

Lance & Spear

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Paramount Surgimed Limited
Manufacturer SRN: IN-MF-000021682
UDI-DI: 08903175089240
Basic UDI-DI: 8903175PSLMYKA2
Reference: PSSML
EMDN: Q030301
EMDN description: ENT SURGERY BLADES, SINGLE-USE
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 01.08.2026 00:13

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ENT UNIT

NET-4000

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mega Medical Co., Ltd.
Manufacturer SRN: KR-MF-000008718
UDI-DI: 18800029902533
Basic UDI-DI: 88000299GTUTL20WB
Reference: NET-4000 / MGSI-CA-ENT UNIT
EMDN: Q0399
EMDN description: ENT DEVICES - OTHER
First on market country: Romania
Authorised representative: KTR Europe GmbH
Last updated: 01.08.2026 00:04

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18800029902502

NET-260SLCB, NET-260SLCB(HD), NET-260SLCB FHD, LS-PT

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mega Medical Co., Ltd.
Manufacturer SRN: KR-MF-000008718
UDI-DI: 18800029902502
Basic UDI-DI: 88000299GTVS10PP
Reference: ENT Endoscopy Visual System / MGSI-CA-260SLCB
EMDN: Q0399
EMDN description: ENT DEVICES - OTHER
First on market country: Romania
Authorised representative: KTR Europe GmbH
Last updated: 01.08.2026 00:04

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ENT Chair

NET-1500D

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mega Medical Co., Ltd.
Manufacturer SRN: KR-MF-000008718
UDI-DI: 18800029902496
Basic UDI-DI: 88000299GTCA10GQ
Reference: NET-1500D / MGSI-CA-ENT UNIT
EMDN: Q0399
EMDN description: ENT DEVICES - OTHER
First on market country: Lithuania
Authorised representative: KTR Europe GmbH
Last updated: 01.08.2026 00:04

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ENT UNIT

NET-600A

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mega Medical Co., Ltd.
Manufacturer SRN: KR-MF-000008718
UDI-DI: 18800029902489
Basic UDI-DI: 88000299GTUTM20WG
Reference: NET-600A / MGSI-CA-ENT UNIT
EMDN: Q0399
EMDN description: ENT DEVICES - OTHER
First on market country: Romania
Authorised representative: KTR Europe GmbH
Last updated: 01.08.2026 00:04

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ENT UNIT

NET-1100

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Mega Medical Co., Ltd.
Manufacturer SRN: KR-MF-000008718
UDI-DI: 18800029902472
Basic UDI-DI: 88000299GTUT20PQ
Reference: NET-1100 / MGSI-CA-ENT UNIT
EMDN: Q0399
EMDN description: ENT DEVICES - OTHER
First on market country: Greece
Authorised representative: KTR Europe GmbH
Last updated: 01.08.2026 00:04

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NAVILLOON-E

MG-BC-0601E, MG-BC-0301E

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Mega Medical Co., Ltd.
Manufacturer SRN: KR-MF-000008718
UDI-DI: 18800029901826
Basic UDI-DI: 88000299SNSS11RW
Reference: Navilloon-e / Catalog ver. 2
EMDN: Q030308
EMDN description: ENT SURGERY DILATORS, SINGLE-USE
First on market country: Spain
Authorised representative: KTR Europe GmbH
Last updated: 01.08.2026 00:04

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OtoMel Oordruppels

Honey ear drops

Class IMDR 2017/745On the market

Manufacturer: DOS Medical B.V.
Manufacturer SRN: NL-MF-000002031
UDI-DI: 08718868380395
Basic UDI-DI: 8718868380982HG
Reference: OTOM10
EMDN: Q03040201
EMDN description: EAR DROPPERS
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:48

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RhinoBlock 15g

RhinoBlock

Class IMDR 2017/745On the market

Manufacturer: DOS Medical B.V.
Manufacturer SRN: NL-MF-000002031
UDI-DI: 08718868380203
Basic UDI-DI: 8718868380975HK
Reference: RHINO15
EMDN: Q0399
EMDN description: ENT DEVICES - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:47

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NasoFree nasal irrigator - 4 sachets

NasoFree

Class IMDR 2017/745On the marketSingle use

Manufacturer: DOS Medical B.V.
Manufacturer SRN: NL-MF-000002031
UDI-DI: 08718868380036
Basic UDI-DI: 8718868380999HZ
Reference: NF04NS
EMDN: Q030103
EMDN description: NASAL IRRIGATION SOLUTIONS
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:47

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08683086103296

3-İN-1 Camera (Kamera)

Class IMDR 2017/745On the marketDirect marking

Manufacturer: MNT Tıbbi Malzemeler San. Tic. Ltd. Şti.
Manufacturer SRN: TR-MF-000039285
UDI-DI: 08683086103296
Basic UDI-DI: 8683086103procam0625HG
Reference: Pro Cam - 0625
EMDN: Q0399
EMDN description: ENT DEVICES - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:27

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fytofontana AURECON plus ear candles

fytofontana AURECON ear candles

Class IMDR 2017/745On the marketSingle use

Manufacturer: Herb-Pharma Corporation s.r.o.
Manufacturer SRN: SK-MF-000005839
UDI-DI: 18588003944747
Basic UDI-DI: 85880039440400104002V5
Reference: 04001
EMDN: Q03040299
EMDN description: EAR IRRIGATION DEVICES - OTHER
First on market country: Slovakia
Authorised representative: -
Last updated: 31.07.2026 23:14

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VINCENTKA® NASALIS startovací sada

Roztoky pro výplach nosu, nosní sliznice

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: VINCENTKA a.s.
Manufacturer SRN: CZ-MF-000032136
UDI-DI: 08594027250132
Basic UDI-DI: 859402725VINCENTKA2N
Reference: VINC0007
EMDN: Q030103
EMDN description: NASAL IRRIGATION SOLUTIONS
First on market country: Czechia
Authorised representative: -
Last updated: 31.07.2026 23:14

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hydropastilky

Pastilky

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: GENERICA, spol. s r.o.
Manufacturer SRN: SK-MF-000036382
UDI-DI: 08588003769992
Basic UDI-DI: 8588003769hp20N2
Reference: 8588003769992
EMDN: Q0399
EMDN description: ENT DEVICES - OTHER
First on market country: Slovakia
Authorised representative: -
Last updated: 31.07.2026 23:10

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AFOMAFORCE EXTRA

SPRAYG3

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: PRANARÔM ESPAÑA S.L.U
Manufacturer SRN: ES-MF-000014215
UDI-DI: 08437023771143
Basic UDI-DI: 8437023771SPRAYG3XW
Reference: 21196
EMDN: Q030103
EMDN description: NASAL IRRIGATION SOLUTIONS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 22:58

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ALLERGOFORCE

SPRAYG2

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: PRANARÔM ESPAÑA S.L.U
Manufacturer SRN: ES-MF-000014215
UDI-DI: 08437023771129
Basic UDI-DI: 8437023771SPRAYG2XU
Reference: 21194
EMDN: Q030103
EMDN description: NASAL IRRIGATION SOLUTIONS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 22:58

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AROMAFORCE

SPRAYG1

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: PRANARÔM ESPAÑA S.L.U
Manufacturer SRN: ES-MF-000014215
UDI-DI: 08437023771105
Basic UDI-DI: 8437023771SPRAYG1XS
Reference: 21192
EMDN: Q030103
EMDN description: NASAL IRRIGATION SOLUTIONS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 22:58

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Multipharma Neusspray Hypertone Oplossing

OZ NASAL SPRAY

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: OKEAN ZALE S.L
Manufacturer SRN: ES-MF-000036705
UDI-DI: 05400519001973
Basic UDI-DI: 843702651401DC
Reference: PT424
EMDN: Q030103
EMDN description: NASAL IRRIGATION SOLUTIONS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 22:57

Manufacturer products View details