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04719873291694

NIV face mask

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: DA CHUNG MEDICAL CO., LTD.
Manufacturer SRN: TW-MF-000037960
UDI-DI: 04719873291694
Basic UDI-DI: 47198732920VN
Reference: 1701
EMDN: R0301010202
EMDN description: NIV MASKS
First on market country: Hungary
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

CPAP Tubing

RAC

Class IMDR 2017/745Not intended for EU marketActive deviceAdministering medicine

Manufacturer: Acare Technology Co., Ltd.
Manufacturer SRN: TW-MF-000031298
UDI-DI: 04719872744283
Basic UDI-DI: 471987274RAX-XXX5K
Reference: RAC-201
EMDN: R03010204
EMDN description: OXYGEN ADMINISTRATION TUBINGS
First on market country: Bulgaria
Authorised representative: Surpass Biomedical Europe B.V.
Last updated: 31.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

Head Strip

CHS

Class IMDR 2017/745Not intended for EU market

Manufacturer: Acare Technology Co., Ltd.
Manufacturer SRN: TW-MF-000031298
UDI-DI: 04719872744290
Basic UDI-DI: 471987274CHS-XXLW
Reference: CHS-03
EMDN: R0301010401
EMDN description: CPAP HELMETS AND KITS
First on market country: -
Authorised representative: Surpass Biomedical Europe B.V.
Last updated: 31.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiopulmonary Resuscitation Pocket Resuscitator Set

CP-66230

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Besmed Health Business Corp.
Manufacturer SRN: TW-MF-000007246
UDI-DI: 04716770662305
Basic UDI-DI: 4716770CP06600DR
Reference: CP-66230
EMDN: R03010201
EMDN description: AIR/OXYGEN MASKS
First on market country: Austria
Authorised representative: Casus Europe B.V.
Last updated: 31.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

FitMax® CPAP Total Face Mask with Standard Elbow and Corrugate Tube, Size: XS

CA-63603

Class IIaMDR 2017/745On the marketAdministering medicineDirect markingReprocessed

Manufacturer: Besmed Health Business Corp.
Manufacturer SRN: TW-MF-000007246
UDI-DI: 04716770636030
Basic UDI-DI: 4716770CA0630179
Reference: CA-63603
EMDN: R0301010201
EMDN description: CPAP MASKS
First on market country: Malta
Authorised representative: Casus Europe B.V.
Last updated: 31.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

MDI Spacer, 220 ml, adult

MD-38240

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Besmed Health Business Corp.
Manufacturer SRN: TW-MF-000007246
UDI-DI: 04716770382005
Basic UDI-DI: 4716770MD03800DU
Reference: MD-38200
EMDN: R03010302
EMDN description: AEROSOL PORTABLE INHALERS
First on market country: Denmark
Authorised representative: Casus Europe B.V.
Last updated: 31.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Neb.Easy Nebulizer Kit

(E) Aerosol Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810085062
Basic UDI-DI: 471081008NNED8B
Reference: AD0044
EMDN: R03010304
EMDN description: AEROSOL THERAPY KITS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

04712832461558

Respirators

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Aero Pro Co., Ltd.
Manufacturer SRN: TW-MF-000012343
UDI-DI: 04712832461558
Basic UDI-DI: 471283246DRTFDA
Reference: AP22103
EMDN: R030199
EMDN description: RESPIRATORY MASKS - OTHER
First on market country: Germany
Authorised representative: KOMAS Medical Technology GmbH
Last updated: 31.07.2026 06:28

Manufacturer products Authorised representative products Authorised representative actors View details

04711064682939

Respiratory accessories

Class IMDR 2017/745On the market

Manufacturer: Hsiner Co., Ltd.
Manufacturer SRN: TW-MF-000007258
UDI-DI: 04711064682939
Basic UDI-DI: 47126880500007258RPASY
Reference: 00003456
EMDN: R030180
EMDN description: RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 31.07.2026 06:27

Manufacturer products Authorised representative products Authorised representative actors View details

Manometer, 0~60cmH2O

(L) Resuscitator

Class IIaMDR 2017/745On the marketMeasuring functionSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810114380
Basic UDI-DI: 471081008NNLP9Q
Reference: AP0006
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:26

Manufacturer products Authorised representative products Authorised representative actors View details

Diverter Cap w/Valve, 30F

(L) Resuscitator

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810113574
Basic UDI-DI: 471081008NNLVA4
Reference: AV0049
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:26

Manufacturer products Authorised representative products Authorised representative actors View details

Headgear for Nasal Mask, White

(A) Headgear

Class IMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810101649
Basic UDI-DI: 471081008NNAM8H
Reference: AM0079
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 06:25

Manufacturer products Authorised representative products Authorised representative actors View details

NHF Prong Kit, #1

(D) Oxygen Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810100673
Basic UDI-DI: 471081008NND67E
Reference: AO0113
EMDN: R03010201
EMDN description: AIR/OXYGEN 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

Gas Sampling Line, 300cm, 4F, 4M

(D) Oxygen Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810089053
Basic UDI-DI: 471081008NND87J
Reference: AB0060
EMDN: R03010201
EMDN description: AIR/OXYGEN 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

Flow Meter Adaptor, White

(D) Oxygen Therapy

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810083969
Basic UDI-DI: 471081008NND97L
Reference: AO0076
EMDN: R03010201
EMDN description: AIR/OXYGEN 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

MR-100 Silicone Reservoir Bag, 1L

(L) Resuscitator

Class IIaMDR 2017/745On the market

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810083464
Basic UDI-DI: 471081008RNL38U
Reference: AR0098
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
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

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

MR-100 NRV, Adult

(L) Resuscitator

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810083136
Basic UDI-DI: 471081008RNL28S
Reference: AR0015
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
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