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06934325308111

Class IIaMDR 2017/745On the marketAdministering medicineDirect marking

Manufacturer: FEELLIFE HEALTH INC.
Manufacturer SRN: CN-MF-000000782
UDI-DI: 06934325308111
Basic UDI-DI: 69343253R03010332E78
Reference: L2
EMDN: R03010301
EMDN description: AEROSOL THERAPY MASKS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

06934325307015

XL7

Class IIaMDR 2017/745On the marketAdministering medicineDirect marking

Manufacturer: FEELLIFE HEALTH INC.
Manufacturer SRN: CN-MF-000000782
UDI-DI: 06934325307015
Basic UDI-DI: 69343253R030132BYJ
Reference: XL7
EMDN: R03010301
EMDN description: AEROSOL THERAPY MASKS
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

06931515008578

Nebulizer mask Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: HOSPITAL&HOMECARE IMP. & EXP. CO.,LTD NANJING
Manufacturer SRN: CN-MF-000038483
UDI-DI: 06931515008578
Basic UDI-DI: 69315150MW107JD
Reference: MW10701001
EMDN: R03010301
EMDN description: AEROSOL THERAPY MASKS
First on market country: Austria
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:49

Manufacturer products Authorised representative products Authorised representative actors View details

06931515061078

Oxygen Mask Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: HOSPITAL&HOMECARE IMP. & EXP. CO.,LTD NANJING
Manufacturer SRN: CN-MF-000038483
UDI-DI: 06931515061078
Basic UDI-DI: 69315150MW105J9
Reference: MW10501001
EMDN: R03010201
EMDN description: AIR/OXYGEN MASKS
First on market country: Austria
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:49

Manufacturer products Authorised representative products Authorised representative actors View details

NIV mask, small, including headgear

Reusable Mask

Class IIaMDR 2017/745On the market

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980112744
Basic UDI-DI: 69239801NR2KASE
Reference: XMR0074
EMDN: R0301010202
EMDN description: NIV MASKS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Neb-1 Nebulizer Kit

Disposable Aerosol therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980111655
Basic UDI-DI: 69239801FD2AEKW
Reference: AD0037
EMDN: R03010304
EMDN description: AEROSOL THERAPY KITS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

NHF Prong Kit, #4

Disposable Oxygen therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980108334
Basic UDI-DI: 69239801ND2MBPL
Reference: AO0011
EMDN: R0301020302
EMDN description: HIGH FLOW THERAPY NASAL CANNULAS (HFNC)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Headgear for Nasal Mask, L

Headgear

Class IMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980106996
Basic UDI-DI: 69239801ND1ECNR
Reference: AM0042
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

M3 Oxygen Masks, L

Disposable Oxygen therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980105937
Basic UDI-DI: 69239801ND2MDPQ
Reference: AO0024
EMDN: R03010201
EMDN description: AIR/OXYGEN MASKS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Neb.Easy w/T-Connector, Tubing

Disposable Aerosol therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980105456
Basic UDI-DI: 69239801FD2ABKQ
Reference: AD0048
EMDN: R03010304
EMDN description: AEROSOL THERAPY KITS
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

Neb.Easy Nebulizer w/Mouth Piece, Tube

Disposable Aerosol therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980105432
Basic UDI-DI: 69239801FD2AFKY
Reference: AD0042
EMDN: R03010304
EMDN description: AEROSOL THERAPY KITS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

CPAP Face Mask Set w/Hose, L

Disposable CPAP Mask

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980104749
Basic UDI-DI: 69239801ND2HAP3
Reference: AM0120
EMDN: R0301010201
EMDN description: CPAP MASKS
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

Adj Venturi (LAV) Adaptor, 22F

Disposable Connector

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980104619
Basic UDI-DI: 69239801ND2GGPC
Reference: AO0001
EMDN: R03010280
EMDN description: OXYGEN THERAPY MASKS AND NASAL CANNULAS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

Neb.Easy AM-1 Mask, Infant w/Tube

Disposable Aerosol therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980103681
Basic UDI-DI: 69239801FD2ACKS
Reference: AD0053
EMDN: R03010304
EMDN description: AEROSOL THERAPY KITS
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

AM-6 Trachea Mask, Adult

Disposable Mask

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980102806
Basic UDI-DI: 69239801ND2KAPC
Reference: AO0108
EMDN: R03010201
EMDN description: AIR/OXYGEN MASKS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

OM-4 Trachea Mask, Adult w/Tubing

Disposable Oxygen therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980102790
Basic UDI-DI: 69239801ND2MEPS
Reference: AO0105
EMDN: R03010205
EMDN description: TRACHEOSTOMY O2 SUPPLIERS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

OM-2 HiO2 Mask, Adult w/Tubing, PVC Bag

Disposable Oxygen therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980102776
Basic UDI-DI: 69239801ND2MFPU
Reference: AO0093
EMDN: R03010206
EMDN description: MASKS WITH RESERVOIR
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

OM-2 Mask, Child w/Tubing

Disposable Oxygen therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980102752
Basic UDI-DI: 69239801ND2MAPJ
Reference: AO0085
EMDN: R03010201
EMDN description: AIR/OXYGEN MASKS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

AM-3 Adj-Venturi Mask, Adult w/Tube

Disposable Oxygen therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980102745
Basic UDI-DI: 69239801ND2MGPW
Reference: AO0079
EMDN: R03010202
EMDN description: VENTURI MASKS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:21

Manufacturer products Authorised representative products Authorised representative actors View details

LVN Nebulizer Kit

Disposable Aerosol therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980102448
Basic UDI-DI: 69239801FD2AAKN
Reference: AD0099
EMDN: R03010304
EMDN description: AEROSOL THERAPY KITS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:20

Manufacturer products Authorised representative products Authorised representative actors View details