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Oxygen Catheter

Plain type

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Well Lead Medical Co., Ltd.
Manufacturer SRN: CN-MF-000006728
UDI-DI: 06936881166921
Basic UDI-DI: 69449327FR01B01K2
Reference: R01B03163Y
EMDN: R0301020301
EMDN description: OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:59

Manufacturer products Authorised representative products Authorised representative actors View details

Welllead Non-Rebreath Mask

Non-Rebreath Mask

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Well Lead Medical Co., Ltd.
Manufacturer SRN: CN-MF-000006728
UDI-DI: 06925816660443
Basic UDI-DI: 69449327FR01A04K3
Reference: R01A04013F
EMDN: R03010201
EMDN description: AIR/OXYGEN MASKS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

Nasal cannula

Please see UDI-DI for details

Class IIaMDR 2017/745On the marketMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053041133
Basic UDI-DI: 69449040AB020000333W
Reference: HF132S
EMDN: R0301020302
EMDN description: HIGH FLOW THERAPY NASAL CANNULAS (HFNC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

Headgear

RA15103

Class IMDR 2017/745On the marketMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053037969
Basic UDI-DI: 69449040AB020000013H
Reference: RA15103
EMDN: R0301020301
EMDN description: OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

Nasal mask

Please see UDI-DI for details

Class IIaMDR 2017/745On the marketMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053006477
Basic UDI-DI: 69449040AB020000023K
Reference: 504-NM(XL)
EMDN: R03010280
EMDN description: OXYGEN THERAPY MASKS AND NASAL CANNULAS - ACCESSORIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:47

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

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

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

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

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

C22 Star Lumen Tubing, 200cm, 6M

Disposable Oxygen tubing

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980100826
Basic UDI-DI: 69239801ND2NBPP
Reference: AO0063
EMDN: R03010204
EMDN description: OXYGEN ADMINISTRATION TUBINGS
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

Oxygen Mask

with tube

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Hangzhou Formed Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000011212
UDI-DI: 06923310902755
Basic UDI-DI: 69233109PA05LY
Reference: PA0500
EMDN: R03010201
EMDN description: AIR/OXYGEN MASKS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:18

Manufacturer products Authorised representative products Authorised representative actors View details

Oxygen Mask with Reservoir Bag

with Bag

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Hangzhou Formed Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000011212
UDI-DI: 06923310902748
Basic UDI-DI: 69233109PA17M7
Reference: PA1700
EMDN: R03010206
EMDN description: MASKS WITH RESERVOIR
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:18

Manufacturer products Authorised representative products Authorised representative actors View details

Gas tube

Silicone

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Hangzhou Formed Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000011212
UDI-DI: 06923310900850
Basic UDI-DI: 69233109PA16079D
Reference: PA160707
EMDN: R03010204
EMDN description: OXYGEN ADMINISTRATION TUBINGS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:18

Manufacturer products Authorised representative products Authorised representative actors View details

Nasal Cannula

Silicone

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Hangzhou Formed Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000011212
UDI-DI: 06923310900669
Basic UDI-DI: 69233109PA16M5
Reference: PA160512
EMDN: R0301020301
EMDN description: OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

Nasal Cannula

PVC

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Hangzhou Formed Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000011212
UDI-DI: 06923310900638
Basic UDI-DI: 69233109PA16018Z
Reference: PA160101
EMDN: R0301020301
EMDN description: OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details