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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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Air-Cush Mask

1691-9005

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 34710961931523
Basic UDI-DI: B-34710961931523
Reference: 1691-9005
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Air-Cush Mask

1691-9004

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 34710961931516
Basic UDI-DI: B-34710961931516
Reference: 1691-9004
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Air-Cush Mask

1691-9003

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 34710961931509
Basic UDI-DI: B-34710961931509
Reference: 1691-9003
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Air-Cush Mask

1691-9002

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 34710961931493
Basic UDI-DI: B-34710961931493
Reference: 1691-9002
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Air-Cush Mask

1691-9001

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 34710961931486
Basic UDI-DI: B-34710961931486
Reference: 1691-9001
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Silicone Mask

1611-9005

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 34710961931400
Basic UDI-DI: B-34710961931400
Reference: 1611-9005
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Silicone Mask

1611-9004

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 34710961931394
Basic UDI-DI: B-34710961931394
Reference: 1611-9004
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Silicone Mask

1611-9003

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 34710961931387
Basic UDI-DI: B-34710961931387
Reference: 1611-9003
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Silicone Mask

1611-9002

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 34710961931370
Basic UDI-DI: B-34710961931370
Reference: 1611-9002
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Silicone Mask

1611-9001

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 34710961931363
Basic UDI-DI: B-34710961931363
Reference: 1611-9001
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Silicone Mask

1611-9000

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 34710961931356
Basic UDI-DI: B-34710961931356
Reference: 1611-9000
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

CONTOUR DELUXE SU W/HEADGEAR, P, DOM/INT – 5 PACK

Contour Deluxe Single Patient Use Nasal Mask and Headstrap

Class IIaMDDNo longer on the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 30606959024824
Basic UDI-DI: B-30606959024824
Reference: 1016980
EMDN: R0301010201
EMDN description: CPAP MASKS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 11.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

SE Nebulizing Elbow Kit, 5 Pack

AF531 Oro-Nasal Single-Use SE with Nebulizing Elbow

Class IIaMDDOn the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 30606959008299
Basic UDI-DI: B-30606959008299
Reference: 1076754
EMDN: R0301010202
EMDN description: NIV MASKS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 11.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

Bronchoscopy Elbow (BE) RP Kit, 5 Pack

Performax Family

Class IIaMDDOn the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 30606959007858
Basic UDI-DI: B-30606959007858
Reference: 1072652
EMDN: R0301010201
EMDN description: CPAP MASKS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 11.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

EE Nebulizing Elbow Kit, 5 Pack

AF531 Oro-Nasal Single-Use EE Leak 1 with Nebulizing Elbow

Class IIaMDDOn the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 30606959007834
Basic UDI-DI: B-30606959007834
Reference: 1072650
EMDN: R0301010201
EMDN description: CPAP MASKS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 11.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

L AF531 SE NE W/CapStrap, SU, 10 Pack

AF531 Oro-Nasal Mask with Nebulizing Elbow

Class IIaMDDNo longer on the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 30606959007353
Basic UDI-DI: B-30606959007353
Reference: 1100438
EMDN: R0301010201
EMDN description: CPAP MASKS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 11.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

M AF531 SE NE W/CapStrap, SU, 10 Pack

AF531 Oro-Nasal Mask with Nebulizing Elbow

Class IIaMDDNo longer on the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 30606959007346
Basic UDI-DI: B-30606959007346
Reference: 1100397
EMDN: R0301010201
EMDN description: CPAP MASKS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 11.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

S AF531 SE NE W/CapStrap, SU, 10 Pack

AF531 Oro-Nasal Mask with Nebulizing Elbow

Class IIaMDDNo longer on the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 30606959007339
Basic UDI-DI: B-30606959007339
Reference: 1100396
EMDN: R0301010201
EMDN description: CPAP MASKS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 11.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

CONTOUR DELUXE SU W/HEADGEAR, M/L, INT

Contour Deluxe Single Patient Use Nasal Mask and Headstrap

Class IIaMDDNo longer on the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 30606959000743
Basic UDI-DI: B-30606959000743
Reference: 1016695
EMDN: R0301010201
EMDN description: CPAP MASKS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 11.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

CONTOUR DELUXE SU W/HEADGEAR, S, INT – 5 PACK

Contour Deluxe Single Patient Use Nasal Mask and Headstrap

Class IIaMDDNo longer on the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 30606959000736
Basic UDI-DI: B-30606959000736
Reference: 1016697
EMDN: R0301010201
EMDN description: CPAP MASKS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 11.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details