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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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25.09.2026 02:28

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Software, Sleepware G3, Web

1115720

Class IIaMDDOn the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959045279
Basic UDI-DI: B-00606959045279
Reference: 1115720
EMDN: Z12100582
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

Sleepware G3 Software Package_ML

1082463

Class IIaMDDOn the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959045262
Basic UDI-DI: B-00606959045262
Reference: 1082463
EMDN: Z12100582
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation BiPAP S/T30 AAM w/Humidifier, DE

DEX1030H13

Class IIbMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959045101
Basic UDI-DI: B-00606959045101
Reference: DEX1030H13
EMDN: Z12030103
EMDN description: PULMONARY VENTILATORS FOR NON–HOSPITAL USE
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation BiPAP S/T30 AAM, DE

DEX1030S13

Class IIbMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959044999
Basic UDI-DI: B-00606959044999
Reference: DEX1030S13
EMDN: Z12030103
EMDN description: PULMONARY VENTILATORS FOR NON–HOSPITAL USE
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation BiPAP S/T30 AAM, no Bluetooth, ZA

ZAX1030S19

Class IIbMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959044975
Basic UDI-DI: B-00606959044975
Reference: ZAX1030S19
EMDN: Z12030103
EMDN description: PULMONARY VENTILATORS FOR NON–HOSPITAL USE
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation BiPAP AVAPS30 AAM, no Bluetooth, ZA

ZAX1130S19

Class IIbMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959044708
Basic UDI-DI: B-00606959044708
Reference: ZAX1130S19
EMDN: Z12030103
EMDN description: PULMONARY VENTILATORS FOR NON–HOSPITAL USE
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:11

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation BiPAP AVAPS30 AAM w/Hum,no Bluetooth, ZA

ZAX1130H19

Class IIbMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959044685
Basic UDI-DI: B-00606959044685
Reference: ZAX1130H19
EMDN: Z12030103
EMDN description: PULMONARY VENTILATORS FOR NON–HOSPITAL USE
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:11

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation BiPAP autoSV, no Bluetooth, ZA

ZAX900S19

Class IIbMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959044531
Basic UDI-DI: B-00606959044531
Reference: ZAX900S19
EMDN: Z12030102
EMDN description: CONTINUOUS POSITIVE PRESSURE EQUIPMENT
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:11

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation BiPAP autoSV w/Humid, no Bluetooth, ZA

ZAX900H19

Class IIbMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959044517
Basic UDI-DI: B-00606959044517
Reference: ZAX900H19
EMDN: Z12030102
EMDN description: CONTINUOUS POSITIVE PRESSURE EQUIPMENT
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:11

Manufacturer products Authorised representative products Authorised representative actors View details

OmniLab Direct Software (ML)

1112033

Class IIbMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959044302
Basic UDI-DI: B-00606959044302
Reference: 1112033
EMDN: Z12159082
EMDN description: VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:11

Manufacturer products Authorised representative products Authorised representative actors View details

CoughAssist, Adpater, 22mm x 22mm

1044186

Class IIaMDDOn the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959043091
Basic UDI-DI: B-00606959043091
Reference: 1044186
EMDN: R05010301
EMDN description: SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:11

Manufacturer products Authorised representative products Authorised representative actors View details

Circuit Filter DEP w/FEP Filter Single, Intl

1073949

Class IIaMDDOn the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959042377
Basic UDI-DI: B-00606959042377
Reference: 1073949
EMDN: Z12030103
EMDN description: PULMONARY VENTILATORS FOR NON–HOSPITAL USE
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:11

Manufacturer products Authorised representative products Authorised representative actors View details

Trilogy, Mouthpiece Ventilation Disposable Circuit

1102869

Class IIaMDDOn the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959043022
Basic UDI-DI: B-00606959043022
Reference: 1102869
EMDN: Z12030103
EMDN description: PULMONARY VENTILATORS FOR NON–HOSPITAL USE
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

FEP Circuit S/A W/O Filters

1069211

Class IIaMDDOn the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959042339
Basic UDI-DI: B-00606959042339
Reference: 1069211
EMDN: Z12030103
EMDN description: PULMONARY VENTILATORS FOR NON–HOSPITAL USE
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation Humidifier GB

GBXH

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959042308
Basic UDI-DI: B-00606959042308
Reference: GBXH
EMDN: R060201
EMDN description: ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

MPV Support System Kit

1102862

Class IIaMDDOn the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959042063
Basic UDI-DI: B-00606959042063
Reference: 1102862
EMDN: Z12030103
EMDN description: PULMONARY VENTILATORS FOR NON–HOSPITAL USE
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

CoughAssist 70 Series, 6ft clear tube

1116178

Class IIaMDDOn the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959041394
Basic UDI-DI: B-00606959041394
Reference: 1116178
EMDN: R05010301
EMDN description: SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

A Series System One Heated Tube Humidifier, Japan

1111556

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959041035
Basic UDI-DI: B-00606959041035
Reference: 1111556
EMDN: R060201
EMDN description: ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation Flow Generator Cover

1128163

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959040199
Basic UDI-DI: B-00606959040199
Reference: 1128163
EMDN: Z12030102
EMDN description: CONTINUOUS POSITIVE PRESSURE EQUIPMENT
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details

Silver Series Heated Humidifier

1120348

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959039643
Basic UDI-DI: B-00606959039643
Reference: 1120348
EMDN: R060201
EMDN description: ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 21.07.2026 23:10

Manufacturer products Authorised representative products Authorised representative actors View details