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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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ComfortGel Blue Mask w/SE, w/Headgear, Petite, INTL

ComfortGel Blue / ProFile Lite Family

Class IIaMDDNo longer on the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020832
Basic UDI-DI: B-00606959020832
Reference: 1070071
EMDN: R0301010202
EMDN description: NIV MASKS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Actical Software

Actiware Software, Actiware CT Software

Class IIaMDDNo longer on the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959021013
Basic UDI-DI: B-00606959021013
Reference: 1081738
EMDN: Z12062599
EMDN description: KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER
First on market country: Bulgaria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

L COMFORTGEL BLUE SE NASAL MASK W/HGR, INTL

ComfortGel Blue Nasal Mask

Class IIaMDDNo longer on the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020818
Basic UDI-DI: B-00606959020818
Reference: 1070068
EMDN: R0301010202
EMDN description: NIV MASKS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

S COMFORTGEL BLUE SE NASAL MASK W/HGR, INTL

ComfortGel Blue Nasal Mask

Class IIaMDDNo longer on the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020825
Basic UDI-DI: B-00606959020825
Reference: 1070070
EMDN: R0301010202
EMDN description: NIV MASKS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

RU Sleeping RTS, Intl

RUSleeping RTS

Class IIaMDDNo longer on the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020566
Basic UDI-DI: B-00606959020566
Reference: 1048540
EMDN: Q03010299
EMDN description: ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alice PDx Unit Only, Warranty Exchange, INTL

Alice PDx System

Class IIaMDDNo longer on the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020689
Basic UDI-DI: B-00606959020689
Reference: 1057624
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alice PDx ExG Yoke, INTL

Alice PDx System

Class IIaMDDNo longer on the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020559
Basic UDI-DI: B-00606959020559
Reference: 1048415
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Actiwatch Spectrum Communication Dock System

Actiwatch 2 and Actiwatch Spectrum

Class IIaMDDNo longer on the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020542
Basic UDI-DI: B-00606959020542
Reference: 1048093
EMDN: Z12062599
EMDN description: KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Actiwatch Spectrum Device

Actiwatch 2 and Actiwatch Spectrum

Class IIaMDDNo longer on the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020535
Basic UDI-DI: B-00606959020535
Reference: 1048091
EMDN: Z12040117
EMDN description: METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

ActiWatch Spectrum System

Actiwatch 2 and Actiwatch Spectrum

Class IIaMDDNo longer on the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020511
Basic UDI-DI: B-00606959020511
Reference: 1046964
EMDN: Z12062599
EMDN description: KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alice PDx Sleep Diagnostic System, INTL

Alice PDx System

Class IIaMDDNo longer on the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020481
Basic UDI-DI: B-00606959020481
Reference: 1043844
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alice PDx ECG Yoke, INTL

Alice PDx System

Class IIaMDDNo longer on the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020450
Basic UDI-DI: B-00606959020450
Reference: 1040810
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

REMSTAR HEATED HUMIDIFIER INTL - RP Kit

REMstar Heated Humidifier

Class IIaMDDNo longer on the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020412
Basic UDI-DI: B-00606959020412
Reference: 1038807
EMDN: R060201
EMDN description: ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,
First on market country: Austria
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alice 5 International Headbox

1017231

Class IIaMDDNo longer on the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020375
Basic UDI-DI: B-00606959020375
Reference: 1017231
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alice 5 International Base Unit Only

1017230

Class IIaMDDNo longer on the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020368
Basic UDI-DI: B-00606959020368
Reference: 1017230
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tubing, 6 ft (1.83m), High-Temp

Breathing Circuit Accessories

Class IIaMDDOn the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020337
Basic UDI-DI: B-00606959020337
Reference: 1007800
EMDN: R02010402
EMDN description: NIV CIRCUITS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

15mm Angled Mouthpiece

PLV Circuit Accessories

Class IIaMDDOn the marketMeasuring functionSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020269
Basic UDI-DI: B-00606959020269
Reference: 1004524
EMDN: R02010199
EMDN description: STANDARD BREATHING CIRCUITS - OTHER
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Alice LE System INTL

Alice 5 and Alice LE Polysomnography Systems

Class IIaMDDNo longer on the marketMeasuring function

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959020245
Basic UDI-DI: B-00606959020245
Reference: 1002288
EMDN: Z12100501
EMDN description: POLYSOMNOGRAPHS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

CoughAssist, Adapter, 22mm x 15mm

CoughAssist Class IIa Accessories

Class IIaMDDOn the marketActive deviceSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959015289
Basic UDI-DI: B-00606959015289
Reference: 1044191
EMDN: R05010301
EMDN description: SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Whisper Swivel II Packaged

Class IIaMDDOn the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959015166
Basic UDI-DI: B-00606959015166
Reference: 332113
EMDN: Z12030102
EMDN description: CONTINUOUS POSITIVE PRESSURE EQUIPMENT
First on market country: Austria
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 04.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details