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Welllead Dcisposable Air Cushion Face Mask

Disposable Air Cushion Face Mask

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Well Lead Medical Co., Ltd.
Manufacturer SRN: CN-MF-000006728
UDI-DI: 06936881180781
Basic UDI-DI: 69449327FA07A00D8
Reference: FA07A05001X
EMDN: R03010101
EMDN description: ANAESTHETIC FACE MASKS
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

Wellleaad Oxygen Mask

Oxygen Mask

Class IIaMDR 2017/745On the marketContains latexSingle use

Manufacturer: Well Lead Medical Co., Ltd.
Manufacturer SRN: CN-MF-000006728
UDI-DI: 06936881167966
Basic UDI-DI: 69449327FR01A01JV
Reference: R01A01011F
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 19:59

Manufacturer products Authorised representative products Authorised representative actors View details

Wellleaad Oxygen Mask

Non-Rebreath Mask with oxygen tubing

Class IIaMDR 2017/745On the marketContains latexSingle use

Manufacturer: Well Lead Medical Co., Ltd.
Manufacturer SRN: CN-MF-000006728
UDI-DI: 06936881166938
Basic UDI-DI: 69449327FR01A00JT
Reference: R01A02018F
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 19:59

Manufacturer products Authorised representative products Authorised representative actors View details

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 Dcisposable Air Cushion Face Mask

Disposable Air Cushion Face Mask

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Well Lead Medical Co., Ltd.
Manufacturer SRN: CN-MF-000006728
UDI-DI: 06936881155901
Basic UDI-DI: 69449327FA07A01DA
Reference: FA07A050710
EMDN: R03010101
EMDN description: ANAESTHETIC FACE 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

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

Bonnet

Please see UDI-DI for details

Class IMDR 2017/745On the marketMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053037792
Basic UDI-DI: 69449040AB0200002947
Reference: RA15201
EMDN: R030180
EMDN description: RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
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

06942272610003

CPR Face Shield

Class IMDR 2017/745On the marketSingle use

Manufacturer: FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)
Manufacturer SRN: CN-MF-000009645
UDI-DI: 06942272610003
Basic UDI-DI: 69422726P5.01.01XW
Reference: FS‐100
EMDN: R030199
EMDN description: RESPIRATORY MASKS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 19:37

Manufacturer products Authorised representative products Authorised representative actors View details

06942272600011

Mouth to Mouth Resuscitation Mask

Class IMDR 2017/745On the marketSingle use

Manufacturer: FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)
Manufacturer SRN: CN-MF-000009645
UDI-DI: 06942272600011
Basic UDI-DI: 69422726P5.01.07YA
Reference: FS-107
EMDN: R030199
EMDN description: RESPIRATORY MASKS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

06941617113926

Endoscopy Mask

Class IIaMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Henan Tuoren Medical Device Co., Ltd
Manufacturer SRN: CN-MF-000013924
UDI-DI: 06941617113926
Basic UDI-DI: 693811937357K7
Reference: EM100310
EMDN: R03010101
EMDN description: ANAESTHETIC FACE MASKS
First on market country: Italy
Authorised representative: MedNet EC-REP C III GmbH
Last updated: 31.07.2026 19:11

Manufacturer products Authorised representative products Authorised representative actors View details

06941617113834

Sillcone mask-Bending edge,Sillcone mask-Detachable type

Class IIaMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Henan Tuoren Medical Device Co., Ltd
Manufacturer SRN: CN-MF-000013924
UDI-DI: 06941617113834
Basic UDI-DI: 693811937356K5
Reference: SMB000
EMDN: R03010101
EMDN description: ANAESTHETIC FACE MASKS
First on market country: Italy
Authorised representative: MedNet EC-REP C III GmbH
Last updated: 31.07.2026 19:11

Manufacturer products Authorised representative products Authorised representative actors View details

06941617109370

Inflatable-Normal type，Inflatable-Soft shell type，Inflatable-Handheld type，Inflatable- Ergo mask

Class IIaMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Henan Tuoren Medical Device Co., Ltd
Manufacturer SRN: CN-MF-000013924
UDI-DI: 06941617109370
Basic UDI-DI: 693811937358K9
Reference: AMS000
EMDN: R03010101
EMDN description: ANAESTHETIC FACE MASKS
First on market country: Italy
Authorised representative: MedNet EC-REP C III GmbH
Last updated: 31.07.2026 19:11

Manufacturer products Authorised representative products Authorised representative actors View details

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