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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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126 device results listed.

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First Breath Headgear - Extra Small (XS) - Qty 1

First Breath Headgear

Class IMDR 2017/745On the marketSingle use

Manufacturer: Viomedex Ltd
Manufacturer SRN: GB-MF-000004399
UDI-DI: 05060195762904
Basic UDI-DI: 506019576VX80119A
Reference: VX8011
EMDN: R0301010401
EMDN description: CPAP HELMETS AND KITS
First on market country: Belgium
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

Head Strip

CHS

Class IMDR 2017/745Not intended for EU market

Manufacturer: Acare Technology Co., Ltd.
Manufacturer SRN: TW-MF-000031298
UDI-DI: 04719872744290
Basic UDI-DI: 471987274CHS-XXLW
Reference: CHS-03
EMDN: R0301010401
EMDN description: CPAP HELMETS AND KITS
First on market country: -
Authorised representative: Surpass Biomedical Europe B.V.
Last updated: 31.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

08906033940097

HavenHood

Class IMDR 2017/745Not intended for EU market

Manufacturer: Phoenix Medical Systems Pvt. Ltd
Manufacturer SRN: IN-MF-000022931
UDI-DI: 08906033940097
Basic UDI-DI: 890603394A140900RP
Reference: Cat.No: 7.2.3- 46
EMDN: R0301010402
EMDN description: NIV HELMETS AND KITS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 18.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

08058323014473

HELMET WITH AIR/OXYGEN BLENDING SYSTEM

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Intersurgical SpA
Manufacturer SRN: IT-MF-000010729
UDI-DI: 08058323014473
Basic UDI-DI: 80583230DCVENTUKIT2V
Reference: CV100L/2
EMDN: R0301010401
EMDN description: CPAP HELMETS AND KITS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:02

Manufacturer products View details

08058323000315

HELMETS FOR NON INVASIVE VENTILATION

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Intersurgical SpA
Manufacturer SRN: IT-MF-000010729
UDI-DI: 08058323000315
Basic UDI-DI: 80583230DCCASCHIKD
Reference: CA012L/2
EMDN: R0301010401
EMDN description: CPAP HELMETS AND KITS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:02

Manufacturer products View details

08057723900195

n.a.

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: HMC PREMEDICAL S.P.A.
Manufacturer SRN: IT-MF-000029438
UDI-DI: 08057723900195
Basic UDI-DI: 8053676296RZIPNESTVF
Reference: 600/5690
EMDN: R0301010402
EMDN description: NIV HELMETS AND KITS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:56

Manufacturer products View details

08058323093805

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Intersurgical SpA
Manufacturer SRN: IT-MF-000010729
UDI-DI: 08058323093805
Basic UDI-DI: 80583230DCCASCHIKD
Reference: CA012LPED/2
EMDN: R0301010401
EMDN description: CPAP HELMETS AND KITS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 22:45

Manufacturer products View details

08058323057272

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Intersurgical SpA
Manufacturer SRN: IT-MF-000010729
UDI-DI: 08058323057272
Basic UDI-DI: 80583230DCCASCHIKD
Reference: CL145INFHI/2Z
EMDN: R0301010401
EMDN description: CPAP HELMETS AND KITS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 22:45

Manufacturer products View details

08058323057319

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Intersurgical SpA
Manufacturer SRN: IT-MF-000010729
UDI-DI: 08058323057319
Basic UDI-DI: 80583230DCCASCHIKD
Reference: CL145INFLO/2Z
EMDN: R0301010401
EMDN description: CPAP HELMETS AND KITS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 22:45

Manufacturer products View details

08058323064430

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Intersurgical SpA
Manufacturer SRN: IT-MF-000010729
UDI-DI: 08058323064430
Basic UDI-DI: 80583230DCCASCHIKD
Reference: CA012S/2W
EMDN: R0301010401
EMDN description: CPAP HELMETS AND KITS
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 14:14

Manufacturer products View details

08058323000360

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Intersurgical SpA
Manufacturer SRN: IT-MF-000010729
UDI-DI: 08058323000360
Basic UDI-DI: 80583230DCCASCHIKD
Reference: CA012M/2W
EMDN: R0301010401
EMDN description: CPAP HELMETS AND KITS
First on market country: -
Authorised representative: -
Last updated: 26.06.2026 02:49

Manufacturer products View details

08058323000445

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Intersurgical SpA
Manufacturer SRN: IT-MF-000010729
UDI-DI: 08058323000445
Basic UDI-DI: 80583230DCCASCHIKD
Reference: CA012XL/2W
EMDN: R0301010401
EMDN description: CPAP HELMETS AND KITS
First on market country: -
Authorised representative: -
Last updated: 26.06.2026 02:49

Manufacturer products View details

First Breath Headgear - Extra Small (XS) - Qty 10