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06975070910082

Non-sterile nebulizer accessory kit

Class IIaMDR 2017/745On the marketAdministering medicineDirect marking

Manufacturer: ShenZhen Bi-rich Medical Devices Co., Ltd
Manufacturer SRN: CN-MF-000023061
UDI-DI: 06975070910082
Basic UDI-DI: 697507091NAKSM
Reference: NAK-SJ-002
EMDN: R03010380
EMDN description: AEROSOL THERAPY SYSTEMS - ACCESSORIES
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

MASKA Z NEBULIZATOREM Z KOMORĄ I DRENEM

YM-A004

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Ningbo Yingmed Medical Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000002183
UDI-DI: 06974580754117
Basic UDI-DI: 697458075A0042F5V
Reference: YM-A004-M
EMDN: R03010301
EMDN description: AEROSOL THERAPY MASKS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 16:37

Manufacturer products Authorised representative products Authorised representative actors View details

Spacer for aerosol

Class IMDR 2017/745On the marketAdministering medicineDirect marking

Manufacturer: Ningbo Yingmed Medical Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000002183
UDI-DI: 06974580750386
Basic UDI-DI: 697458075A039GU
Reference: YM-A018
EMDN: R03010302
EMDN description: AEROSOL PORTABLE INHALERS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 16:36

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Medicine Chamber Spacer

Class IMDR 2017/745On the marketAdministering medicine

Manufacturer: Dongguan Rongrui-Century Science & Technology Co., Ltd
Manufacturer SRN: CN-MF-000032795
UDI-DI: 06974226681197
Basic UDI-DI: 697422668RVCVG
Reference: RVC002（Oral inhalation）
EMDN: R03010302
EMDN description: AEROSOL PORTABLE INHALERS
First on market country: Germany
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 15:45

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Portable Mesh Nebulizer kit

YM-3RB

Class IIaMDR 2017/745On the marketAdministering medicineDirect markingSingle use

Manufacturer: Shenzhen IMDK Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024290
UDI-DI: 06973912940433
Basic UDI-DI: 697391294701RBAF
Reference: YM-3RB
EMDN: R03010304
EMDN description: AEROSOL THERAPY KITS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

IMDK

YM-3R9, YM-3R6, YM-3R7, YM-3R8, YM-3R9L, YM-3R8L, YM-3R6L

Class IIaMDR 2017/745On the marketActive deviceAdministering medicineDirect marking

Manufacturer: Shenzhen IMDK Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024290
UDI-DI: 06973912940006
Basic UDI-DI: 697391294301NEB4M
Reference: YM-3R9
EMDN: R03010302
EMDN description: AEROSOL PORTABLE INHALERS
First on market country: Greece
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:15

Manufacturer products Authorised representative products Authorised representative actors View details

AEROFLUX

INHALATION CHAMBER

Class IMDR 2017/745On the market

Manufacturer: Nexmed Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000013262
UDI-DI: 06973127140284
Basic UDI-DI: 697312714NXM003K8
Reference: AX-P6
EMDN: R03010302
EMDN description: AEROSOL PORTABLE INHALERS
First on market country: France
Authorised representative: BYO-TECH SAS
Last updated: 02.07.2026 13:40

Manufacturer products Authorised representative products Authorised representative actors View details

Face masks

GS、GM、GL、PS、PM、PL、GS1、GM1、GL1、PS1、PM1、PL1

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Ningbo MFLAB Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000032006
UDI-DI: 06971956735404
Basic UDI-DI: 697195673540PQ
Reference: GS
EMDN: R03010301
EMDN description: AEROSOL THERAPY MASKS
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

AEROCHAMBER WITH MASK

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Yuyao Hairui Medical Device Co., Ltd.
Manufacturer SRN: CN-MF-000041902
UDI-DI: 06971249492854
Basic UDI-DI: 697124949HRA03JX
Reference: HR03A-500
EMDN: R03010302
EMDN description: AEROSOL PORTABLE INHALERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

AEROCHAMBER WITH MASK

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Yuyao Hairui Medical Device Co., Ltd.
Manufacturer SRN: CN-MF-000041902
UDI-DI: 06971249492755
Basic UDI-DI: 697124949HRA02JV
Reference: HR02A-350
EMDN: R03010302
EMDN description: AEROSOL PORTABLE INHALERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

AEROCHAMBER WITH MASK

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Yuyao Hairui Medical Device Co., Ltd.
Manufacturer SRN: CN-MF-000041902
UDI-DI: 06971249492502
Basic UDI-DI: 697124949HRA01JT
Reference: HR01A-175
EMDN: R03010302
EMDN description: AEROSOL PORTABLE INHALERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Nebulizer Masks for Single Use

WHQ-01-01

Class IIaMDR 2017/745Not intended for EU marketDirect markingSingle use

Manufacturer: Shaoxing Undis Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000002187
UDI-DI: 16970531333018
Basic UDI-DI: 697053133nmsu2Q
Reference: S
EMDN: R03010301
EMDN description: AEROSOL THERAPY MASKS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 11:33

Manufacturer products Authorised representative products Authorised representative actors View details

Welllead Mesh Nebulizer Kit

AeroTank Kit

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Well Lead Medical Co., Ltd.
Manufacturer SRN: CN-MF-000006728
UDI-DI: 06925816646331
Basic UDI-DI: 69449327FR01E04KP
Reference: R01L021010
EMDN: R03010304
EMDN description: AEROSOL THERAPY KITS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

Welllead Mesh Nebulizer Kit

Mesh Nebulizer Kit Basic

Class IIaMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Well Lead Medical Co., Ltd.
Manufacturer SRN: CN-MF-000006728
UDI-DI: 06925816646157
Basic UDI-DI: 69449327FR01E00KF
Reference: R01L011010
EMDN: R03010304
EMDN description: AEROSOL THERAPY KITS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

FINDAIR ONE for Diskus

Class IMDR 2017/745On the marketActive deviceDirect markingSingle use

Manufacturer: FindAir Sp. z o. o.
Manufacturer SRN: PL-MF-000037094
UDI-DI: 05905996902053
Basic UDI-DI: 59059969020DiskusJ6
Reference: 5
EMDN: R03010380
EMDN description: AEROSOL THERAPY SYSTEMS - ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 06:15

Manufacturer products View details

FINDAIR ONE for Easyhaler

FindAir ONE CapsoClick

Class IMDR 2017/745On the marketActive device

Manufacturer: FindAir Sp. z o. o.
Manufacturer SRN: PL-MF-000037094
UDI-DI: 05905996902039
Basic UDI-DI: 59059969020EasyHE
Reference: 6
EMDN: R03010380
EMDN description: AEROSOL THERAPY SYSTEMS - ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 06:15

Manufacturer products View details

Relenza

Diskhaler

Class IIaMDR 2017/745On the marketAdministering medicineDirect marking

Manufacturer: GlaxoSmithKline Trading Services Limited
Manufacturer SRN: IE-MF-000008351
UDI-DI: 85054363000444
Basic UDI-DI: 5054363591603257BA
Reference: GLA28050A
EMDN: R03010302
EMDN description: AEROSOL PORTABLE INHALERS
First on market country: France
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

Babyhaler

Class IMDR 2017/745On the marketAdministering medicine

Manufacturer: GlaxoSmithKline Trading Services Limited
Manufacturer SRN: IE-MF-000008351
UDI-DI: 85054363000260
Basic UDI-DI: 5054363591190289C4
Reference: 28003140
EMDN: R03010380
EMDN description: AEROSOL THERAPY SYSTEMS - ACCESSORIES
First on market country: Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

Volumatic Spacer Device

Volumatic

Class IIaMDR 2017/745On the marketAdministering medicine

Manufacturer: GlaxoSmithKline Trading Services Limited
Manufacturer SRN: IE-MF-000008351
UDI-DI: 85054363000000
Basic UDI-DI: 5054363591191345BU
Reference: 28003170
EMDN: R03010380
EMDN description: AEROSOL THERAPY SYSTEMS - ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

04015672114166

NEB-ASKIT-16E

Class IIaMDR 2017/745On the marketAdministering medicine

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04015672114166
Basic UDI-DI: 40156721141658
Reference: NEB-ASKIT-16E
EMDN: R03010304
EMDN description: AEROSOL THERAPY KITS
First on market country: Netherlands
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 01.07.2026 16:48

Manufacturer products Authorised representative products Authorised representative actors View details