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EUDAMED Device Search

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AM-2 Aerosol Mask, Child

(E) Aerosol Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810082788
Basic UDI-DI: 471081008NNE37B
Reference: AD0068
EMDN: R03010301
EMDN description: AEROSOL THERAPY MASKS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

LVN Nebulizer, PP

(E) Aerosol Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810082085
Basic UDI-DI: 471081008NNE47D
Reference: AH0032
EMDN: R03010304
EMDN description: AEROSOL THERAPY KITS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:24

Manufacturer products Authorised representative products Authorised representative actors View details

Isolated Nebulizer Kit

(E) Aerosol Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810081835
Basic UDI-DI: 471081008NNE57F
Reference: AD0035
EMDN: R03010304
EMDN description: AEROSOL THERAPY KITS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:24

Manufacturer products Authorised representative products Authorised representative actors View details

Neb-1 Nebulizer Kit

(E) Aerosol Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810081828
Basic UDI-DI: 471081008NNED8B
Reference: AD0037
EMDN: R03010303
EMDN description: AEROSOL THERAPY TUBINGS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:24

Manufacturer products Authorised representative products Authorised representative actors View details

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

(E) Aerosol Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810080586
Basic UDI-DI: 471081008NNE177
Reference: AD0049
EMDN: R03010301
EMDN description: AEROSOL THERAPY MASKS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:23

Manufacturer products Authorised representative products Authorised representative actors View details

HandiHaler

Class IIaMDR 2017/745On the marketAdministering medicineDirect marking

Manufacturer: Boehringer Ingelheim Pharma GmbH & Co. KG
Manufacturer SRN: DE-MF-000015595
UDI-DI: 04065477000010
Basic UDI-DI: 4065477HANDIHALERRH
Reference: HH OEFFHI KAMMER AUS PC EU/ROW / 87712
EMDN: R03010302
EMDN description: AEROSOL PORTABLE INHALERS
First on market country: Netherlands
Authorised representative: -
Last updated: 30.07.2026 23:21

Manufacturer products View details

Respimat

Class IIbMDR 2017/745On the marketActive deviceAdministering medicineDirect marking

Manufacturer: Boehringer Ingelheim Pharma GmbH & Co. KG
Manufacturer SRN: DE-MF-000015595
UDI-DI: 04065477001017
Basic UDI-DI: 4065477RESPIMATEJ
Reference: INH RES A5.2 BERO 120HUB GUMD / 84976
EMDN: R03010302
EMDN description: AEROSOL PORTABLE INHALERS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:21

Manufacturer products View details

I-Guard Aerosol Mask (Adult), elastic strap fixation

Salter Labs Aerosol Masks

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Salter Labs
Manufacturer SRN: US-MF-000007934
UDI-DI: 20607411102039
Basic UDI-DI: 0607411TF20013aAersMaskM5
Reference: 8107V-0-50
EMDN: R03010301
EMDN description: AEROSOL THERAPY MASKS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 30.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

08437028850010

MASCARILLA SILICONA

Class IMDR 2017/745On the marketSingle use

Manufacturer: Reiner Medtech S.L.U
Manufacturer SRN: ES-MF-000048477
UDI-DI: 08437028850010
Basic UDI-DI: 8437028850MAS1000000110T8
Reference: 00600INT000
EMDN: R03010301
EMDN description: AEROSOL THERAPY MASKS
First on market country: Spain
Authorised representative: -
Last updated: 27.07.2026 04:58

Manufacturer products View details

04975479498893

NEB-DMC1-20AP

Class IIaMDR 2017/745Not intended for EU marketSingle use

Manufacturer: OMRON Healthcare Co., Ltd.
Manufacturer SRN: JP-MF-000007213
UDI-DI: 04975479498893
Basic UDI-DI: 497547949889RA
Reference: NEB-DMC1-20AP
EMDN: R03010399
EMDN description: AEROSOL THERAPY SYSTEMS - OTHER
First on market country: -
Authorised representative: OMRON Healthcare Europe B.V.
Last updated: 25.07.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

04975479498626

NEB-NSETB-8AAP