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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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867 device results listed.

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Silicone Mask

1611-9000

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 64710961931357
Basic UDI-DI: B-64710961931357
Reference: 1611-9000
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 03:40

Manufacturer products Authorised representative products Authorised representative actors View details

Silicone C.W.V. Reservoir

2013-0615

Class IMDDOn the marketSingle useSterile

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 54710961934849
Basic UDI-DI: B-54710961934849
Reference: 2013-0615
EMDN: A0601010199
EMDN description: DRAINAGE SYSTEMS WITH PREDEFINED SUCTION - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 02:40

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: 54710961931374
Basic UDI-DI: B-54710961931374
Reference: 1611-9002
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 02:40

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: 54710961931367
Basic UDI-DI: B-54710961931367
Reference: 1611-9001
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 02:40

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: 54710961931350
Basic UDI-DI: B-54710961931350
Reference: 1611-9000
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 02:40

Manufacturer products Authorised representative products Authorised representative actors View details

Rystora® Silicone Scar Sheet (Non-sterile)

SAR251500

Class IMDR 2017/745On the market

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04711182607029
Basic UDI-DI: 471096193000901FL
Reference: SA101812
EMDN: M0499
EMDN description: SPECIAL DRESSINGS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

Head Strap for ET tube Fixation Device

1500-0101

Class IMDR 2017/745On the market

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04711182606985
Basic UDI-DI: 471096193001401F2
Reference: 1500-0111
EMDN: V80
EMDN description: CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

Rystora® Silicone Scar Sheet (Non-sterile)

Class INot specifiedOn the market

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04711182628758
Basic UDI-DI: 471096193000901FL
Reference: SA101801
EMDN: M0499
EMDN description: SPECIAL DRESSINGS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 13.07.2026 06:45

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: 74710961931378
Basic UDI-DI: B-74710961931378
Reference: 1611-9002
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 12.07.2026 09:01

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: 74710961931361
Basic UDI-DI: B-74710961931361
Reference: 1611-9001
EMDN: R03010180
EMDN description: ARTIFICIAL VENTILATION MASKS - ACCESSORIES
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 12.07.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

"Fortune" Laryngeal Mask Tube (Non-Sterile)

1580-0020

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 44711182603111
Basic UDI-DI: B-44711182603111
Reference: 1580-0020
EMDN: R01020101
EMDN description: LARYNGEAL MASKS, SINGLE-LUMEN
First on market country: Malta
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

Silicone C.W.V. Reservoir

2013-0610

Class IMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 44710961934835
Basic UDI-DI: B-44710961934835
Reference: 2013-0610
EMDN: A0601010199
EMDN description: DRAINAGE SYSTEMS WITH PREDEFINED SUCTION - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

Air-Cush Mask

1691-9005

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 44710961931520
Basic UDI-DI: B-44710961931520
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 19:44

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: 44710961931513
Basic UDI-DI: B-44710961931513
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 19:44

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: 44710961931407
Basic UDI-DI: B-44710961931407
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 19:43

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: 44710961931353
Basic UDI-DI: B-44710961931353
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 19:43

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: 44710961931377
Basic UDI-DI: B-44710961931377
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 19:43

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: 44710961931360
Basic UDI-DI: B-44710961931360
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 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Silicone Penrose Drain Tube W/ Secure-Clip

2010-5412

Class IIaMDDOn the marketSingle useSterile

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 34711182604852
Basic UDI-DI: B-34711182604852
Reference: 2010-5412
EMDN: A06010199
EMDN description: VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER
First on market country: Denmark
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

Silicone Penrose Drain Tube W/ Secure-Clip

2010-5408

Class IIaMDDOn the marketSingle useSterile

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 34711182604838
Basic UDI-DI: B-34711182604838
Reference: 2010-5408
EMDN: A06010199
EMDN description: VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER
First on market country: Denmark
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details