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PEP Aircushion Mask, L

(M) Non invasive ventilation (NIV) Mask

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810083174
Basic UDI-DI: 471081008NNMM9M
Reference: AM0036
EMDN: R0301010201
EMDN description: CPAP 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

Neb.Easy Nebulizer, 18M

(E) Aerosol Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810082962
Basic UDI-DI: 471081008NNE279
Reference: AD0002
EMDN: R03010304
EMDN description: AEROSOL THERAPY KITS
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

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

AM-4 Trachea Mask, Adult

(D) Oxygen Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810082573
Basic UDI-DI: 471081008NND57C
Reference: AO0006
EMDN: R03010202
EMDN description: VENTURI MASKS
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

OM-2 Mask, Child

(D) Oxygen Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810082092
Basic UDI-DI: 471081008NND276
Reference: AO0005
EMDN: R03010201
EMDN description: AIR/OXYGEN MASKS
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

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

C22 Star Lumen Tubing, 1000cm

(D) Oxygen Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810082054
Basic UDI-DI: 471081008NND174
Reference: AO0065
EMDN: R03010201
EMDN description: AIR/OXYGEN MASKS
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

OM-3 HiO2 Mask, Child w/Tubing, PVC Bag

(D) Oxygen Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810081934
Basic UDI-DI: 471081008NND378
Reference: AO0097
EMDN: R03010201
EMDN description: AIR/OXYGEN MASKS
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

Softip-3 Nasal Cannula, Child

(D) Oxygen Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810081927
Basic UDI-DI: 471081008NNDO8W
Reference: AO0071
EMDN: R03010201
EMDN description: AIR/OXYGEN MASKS
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

AM-1 Venturi Mask, Adult

(D) Oxygen Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810081538
Basic UDI-DI: 471081008NND47A
Reference: AO0098
EMDN: R03010202
EMDN description: VENTURI MASKS
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

Headgear for CPAP Mask, S, Silicone

(A) Headgear

Class IMDR 2017/745On the market

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810081439
Basic UDI-DI: 471081008RNAM9D
Reference: AM0015
EMDN: R030180
EMDN description: RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
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

Sil.Flex Mask, #0

(O) Mask

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810080319
Basic UDI-DI: 471081008RNOMAP
Reference: AM0004
EMDN: R03010201
EMDN description: AIR/OXYGEN 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

Bonnets xx small

Neojet 2000 nCPAP Bonnet

Class IMDR 2017/745On the marketSingle use

Manufacturer: Löwenstein Medical SE & Co. KG
Manufacturer SRN: DE-MF-000006028
UDI-DI: 04260171271616
Basic UDI-DI: 426017127NeoJetRM
Reference: nj1513-10e
EMDN: R03010280
EMDN description: OXYGEN THERAPY MASKS AND NASAL CANNULAS - ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:39

Manufacturer products View details

Paediatric Mask; Newborn #0; 15 mm O.D.

Face Masks - Paediatric Mask

Class IIaMDR 2017/745On the market

Manufacturer: VBM Medizintechnik GmbH
Manufacturer SRN: DE-MF-000005907
UDI-DI: 14250105630524
Basic UDI-DI: 42501056-1.5.7-W5
Reference: 88-11-000
EMDN: R03010101
EMDN description: ANAESTHETIC FACE MASKS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

Bi-Mask 2; 22 mm I.D.

Face Masks - Bi-Mask

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: VBM Medizintechnik GmbH
Manufacturer SRN: DE-MF-000005907
UDI-DI: 14250105629580
Basic UDI-DI: 42501056-1.5.3-VR
Reference: 35-65-222
EMDN: R03010101
EMDN description: ANAESTHETIC FACE MASKS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:49

Manufacturer products View details

Endoscopy Mask; small Ø 2 mm; tubing: 15 mm O.D.; 155 mm

Face Masks - Endoscopy Mask

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: VBM Medizintechnik GmbH
Manufacturer SRN: DE-MF-000005907
UDI-DI: 04250105629750
Basic UDI-DI: 42501056-1.5.2-VN
Reference: 30-40-111
EMDN: R03010101
EMDN description: ANAESTHETIC FACE MASKS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:41

Manufacturer products View details

Face Mask; Adult, small #4; 22 mm I.D.

Face Masks - PVC Face Mask

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: VBM Medizintechnik GmbH
Manufacturer SRN: DE-MF-000005907
UDI-DI: 04250105600018
Basic UDI-DI: 42501056-1.5.1-VK
Reference: 35-40-204
EMDN: R03010101
EMDN description: ANAESTHETIC FACE MASKS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:40

Manufacturer products View details