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06977206050990

LB4010

Class IMDR 2017/745On the marketSingle use

Manufacturer: Ningbo Foyomed Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000032266
UDI-DI: 06977206050990
Basic UDI-DI: 697720605Humidifier01JZ
Reference: LB4010
EMDN: R060280
EMDN description: HUMIDIFICATION SYSTEMS - ACCESSORIES
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 22:18

Manufacturer products Authorised representative products Authorised representative actors View details

06975338561001

SD-H01

Class IMDR 2017/745On the marketActive device

Manufacturer: WENZHOU SHENGDING INDUSTRY & TRADE CO.,LTD
Manufacturer SRN: CN-MF-000009818
UDI-DI: 06975338561001
Basic UDI-DI: 697533856humidifierGN
Reference: SD-H01
EMDN: R060280
EMDN description: HUMIDIFICATION SYSTEMS - ACCESSORIES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

06974340680205

NatrFlow

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shenzhen SunnyGrand Healthcare Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000017209
UDI-DI: 06974340680205
Basic UDI-DI: 697434068A121D8
Reference: NatrFlow 40H
EMDN: R060201
EMDN description: ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,
First on market country: Ireland
Authorised representative: Wellkang Ltd
Last updated: 02.07.2026 15:55

Manufacturer products Authorised representative products Authorised representative actors View details

Heated humidifiers

HK-H100，HK-D100

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Ningbo Huakun Medical Equipment Co., Ltd.
Manufacturer SRN: CN-MF-000008459
UDI-DI: 06973504019981
Basic UDI-DI: 697350401H1009X
Reference: HK-H100
EMDN: R060201
EMDN description: ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:41

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable Chamber Kit

KT842

Class IIaMDR 2017/745On the market

Manufacturer: HEYER Medical Co., Ltd.
Manufacturer SRN: CN-MF-000014712
UDI-DI: 06972733990771
Basic UDI-DI: 697273399060280HSA9G
Reference: 111500055
EMDN: R060280
EMDN description: HUMIDIFICATION SYSTEMS - ACCESSORIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

6971066425639

Nebulizer

Class IIaMDR 2017/745On the marketActive deviceAdministering medicineReusable

Manufacturer: Foshan Hongfeng Co. Ltd.
Manufacturer SRN: CN-MF-000016042
UDI-DI: 6971066425639
Basic UDI-DI: 697106642BC6800636
Reference: BC68006
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Denmark
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 11:34

Manufacturer products Authorised representative products Authorised representative actors View details

FOFO

BC68001-E

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Foshan Hongfeng Co. Ltd.
Manufacturer SRN: CN-MF-000016042
UDI-DI: 6971066420696
Basic UDI-DI: 69710664268001-EN4
Reference: BC68001-E
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 11:34

Manufacturer products Authorised representative products Authorised representative actors View details

GALENA

BC-68002

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Foshan Hongfeng Co. Ltd.
Manufacturer SRN: CN-MF-000016042
UDI-DI: 6971066420498
Basic UDI-DI: 697106642BC680022W
Reference: BC68002
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 11:34

Manufacturer products Authorised representative products Authorised representative actors View details

06971066429439

BC68001

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Foshan Hongfeng Co. Ltd.
Manufacturer SRN: CN-MF-000016042
UDI-DI: 06971066429439
Basic UDI-DI: 697106642BC680012U
Reference: BC68001
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Finland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 11:31

Manufacturer products Authorised representative products Authorised representative actors View details

FOFO

Compressor Nebulizer

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Foshan Hongfeng Co. Ltd.
Manufacturer SRN: CN-MF-000016042
UDI-DI: 06971066420450
Basic UDI-DI: 69710664268000XU
Reference: 0001
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 11:30

Manufacturer products Authorised representative products Authorised representative actors View details

16975984064557

Hi-OT1

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 16975984064557
Basic UDI-DI: 6970341680112300GW
Reference: NA
EMDN: R060280
EMDN description: HUMIDIFICATION SYSTEMS - ACCESSORIES
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

16975984064526

Hi-NAI-L, Hi-NAI-M, Hi-NAI-S

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 16975984064526
Basic UDI-DI: 6970341680112301GY
Reference: NA
EMDN: R060280
EMDN description: HUMIDIFICATION SYSTEMS - ACCESSORIES
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

06975984064505

Hi-800, Hi-600

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064505
Basic UDI-DI: 6970341680111901HP
Reference: /
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

Durable Chamber, Adult

Reusable Humidification Chamber

Class IIaMDR 2017/745On the market

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 26923980102183
Basic UDI-DI: 69239801NR2FARX
Reference: AH0021
EMDN: R060280
EMDN description: HUMIDIFICATION SYSTEMS - ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 02.07.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

WILAQUA

Water for Inhalation

Class IIbMDR 2017/745On the market

Manufacturer: ΒΙΟΣΕΡ Α.Ε. ΒΙΟΜΗΧΑΝΙΑ ΠΑΡΕΝΤΕΡΙΚΩΝ ΔΙΑΛΥΜΑΤΩΝ
Manufacturer SRN: GR-MF-000013176
UDI-DI: 05200702400589
Basic UDI-DI: 52007024WATERINHALATION4F
Reference: 500186
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Germany
Authorised representative: -
Last updated: 02.07.2026 02:50

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Vent Filter Set

Ventilation Filters

Class IIaMDR 2017/745On the market

Manufacturer: GVS Filter Technology UK Limited
Manufacturer SRN: UK-MF-000045036
UDI-DI: 05056845200018
Basic UDI-DI: 506012095Cat47B
Reference: 2000/05BAKZTRA001/0001
EMDN: R060299
EMDN description: HUMIDIFICATION SYSTEMS - OTHER
First on market country: Italy
Authorised representative: GVS S.p.A.
Last updated: 02.07.2026 02:04

Manufacturer products Authorised representative products Authorised representative actors View details

Vent Filter Set

Gas and Suction Filters

Class IMDR 2017/745On the market

Manufacturer: GVS Filter Technology UK Limited
Manufacturer SRN: UK-MF-000045036
UDI-DI: 05056845200001
Basic UDI-DI: 506012095Class1L9
Reference: 2000/05BAKBARA001/0001
EMDN: R060299
EMDN description: HUMIDIFICATION SYSTEMS - OTHER
First on market country: Italy
Authorised representative: GVS S.p.A.
Last updated: 02.07.2026 02:04

Manufacturer products Authorised representative products Authorised representative actors View details

inspired™

VHC60, VHC65

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: VINCENT MEDICAL MANUFACTURING CO., LIMITED
Manufacturer SRN: CN-MF-000035808
UDI-DI: 14896138011178
Basic UDI-DI: 4896138O2FLOChamberGL
Reference: 51006136
EMDN: R060280
EMDN description: HUMIDIFICATION SYSTEMS - ACCESSORIES
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 00:46

Manufacturer products Authorised representative products Authorised representative actors View details

SoftBreezer® with 6% NaCl

Inhalation Solution

Class IIbMDR 2017/745On the marketSterile

Manufacturer: Penta Arzneimittel GmbH
Manufacturer SRN: DE-MF-000006565
UDI-DI: 14260595532093
Basic UDI-DI: 426059553MP29SB01LJ
Reference: 41115800
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:53

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SoftBreezer® with 3% NaCl

Inhalation Solution

Class IIbMDR 2017/745On the marketSterile

Manufacturer: Penta Arzneimittel GmbH
Manufacturer SRN: DE-MF-000006565
UDI-DI: 14260595532086
Basic UDI-DI: 426059553MP28SB01L7
Reference: 41113900
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:53

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