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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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WiZARD 520

Class IIaMDDOn the market

Manufacturer: Wellell Inc.
Manufacturer SRN: TW-MF-000009159
UDI-DI: 04713025001001
Basic UDI-DI: B-04713025001001
Reference: SM12001
EMDN: R0301010201
EMDN description: CPAP MASKS
First on market country: Spain
Authorised representative: Wellell Iberia S.L.
Last updated: 02.08.2026 12:49

Manufacturer products Authorised representative products Authorised representative actors View details

1691-9005

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931522
Basic UDI-DI: B-04710961931522
Reference: 1691-9005
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

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1691-9004

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931515
Basic UDI-DI: B-04710961931515
Reference: 1691-9005
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

Manufacturer products Authorised representative products Authorised representative actors View details

1691-9003

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931508
Basic UDI-DI: B-04710961931508
Reference: 1691-9003
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

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1691-9002

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931492
Basic UDI-DI: B-04710961931492
Reference: 1691-9002
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

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1691-9001

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931485
Basic UDI-DI: B-04710961931485
Reference: 1691-9001
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

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1611-9005

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931409
Basic UDI-DI: B-04710961931409
Reference: 1611-9005
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

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1611-9004

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931393
Basic UDI-DI: B-04710961931393
Reference: 1611-9004
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

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1611-9003

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931386
Basic UDI-DI: B-04710961931386
Reference: 1611-9003
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

Manufacturer products Authorised representative products Authorised representative actors View details

1611-9002

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931379
Basic UDI-DI: B-04710961931379
Reference: 1611-9002
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

Manufacturer products Authorised representative products Authorised representative actors View details

1611-9001

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931362
Basic UDI-DI: B-04710961931362
Reference: 1611-9001
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

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1611-9000

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931355
Basic UDI-DI: B-04710961931355
Reference: 1611-9000
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable Nasal Oxygen Cannula

-

Class IIaMDR 2017/745Not intended for EU marketSingle use

Manufacturer: Jiangsu Hanbo Medical Equipment Co., Ltd.
Manufacturer SRN: CN-MF-000027198
UDI-DI: 16975519160150
Basic UDI-DI: 697551916NOCV8
Reference: NOC-Adult-01
EMDN: R0301020301
EMDN description: OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 02.08.2026 09:05

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable Nasal Oxygen Cannula

-

Class IIaMDR 2017/745Not intended for EU marketSingle use

Manufacturer: Jiangsu Hanbo Medical Equipment Co., Ltd.
Manufacturer SRN: CN-MF-000027198
UDI-DI: 16975519160174
Basic UDI-DI: 697551916NOCV8
Reference: NOC-Adult-03
EMDN: R0301020301
EMDN description: OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 02.08.2026 09:05

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Firesafe Cannula Valve

-

Class IIaNot specifiedOn the marketDirect markingSingle use

Manufacturer: BPR Medical Limited
Manufacturer SRN: GB-MF-000003347
UDI-DI: 05060274504234
Basic UDI-DI: 50602745000667
Reference: 827-2001
EMDN: R03010280
EMDN description: OXYGEN THERAPY MASKS AND NASAL CANNULAS - ACCESSORIES
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

LiteTouch Large Mask/Grand Masque

LiteTouch Large Mask/Grand Masque

Class IMDDOn the marketReusable

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00383730000800
Basic UDI-DI: B-00383730000800
Reference: 1082716
EMDN: R030199
EMDN description: RESPIRATORY MASKS - OTHER
First on market country: Austria
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 01.08.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

LiteTouch

Class IMDDOn the marketReusable

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00383730000794
Basic UDI-DI: B-00383730000794
Reference: 1083783
EMDN: R030199
EMDN description: RESPIRATORY MASKS - OTHER
First on market country: Austria
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 01.08.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

LiteTouch Medium Mask/Masque Moyen

LiteTouch Medium Mask/Masque Moyen

Class IMDDOn the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00383730000770
Basic UDI-DI: B-00383730000770
Reference: 1082715
EMDN: R030199
EMDN description: RESPIRATORY MASKS - OTHER
First on market country: Austria
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 01.08.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

LiteTouch

Class IMDDOn the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00383730000749
Basic UDI-DI: B-00383730000749
Reference: 1083785
EMDN: R030199
EMDN description: RESPIRATORY MASKS - OTHER
First on market country: Austria
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 01.08.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

LiteTouch Small Mask/Petit Masque

LiteTouch Small Mask/Petit Masque

Class IMDDOn the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00383730000732
Basic UDI-DI: B-00383730000732
Reference: 1082714
EMDN: R030199
EMDN description: RESPIRATORY MASKS - OTHER
First on market country: Austria
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 01.08.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details