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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Filtered Exhalation Port (FEP) FPH 150PK

1140613

Class IIaMDDOn the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959418905
Basic UDI-DI: B-00606959418905
Reference: 1140613
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation BiPAP AVAPS30, GB Rental

RGBX1130S20

Class IIbMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959418721
Basic UDI-DI: B-00606959418721
Reference: RGBX1130S20
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

Filtered Exhalation Port (FEP) S/A, 150PK

1134664

Class IIaMDDOn the marketSingle use

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959416185
Basic UDI-DI: B-00606959416185
Reference: 1134664
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation BiPAP autoSV, DE Rental

RDEX900S13

Class IIbMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959413856
Basic UDI-DI: B-00606959413856
Reference: RDEX900S13
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation BiPAP autoSV w/ Humid, GB Rental

RGBX900H15

Class IIbMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959413849
Basic UDI-DI: B-00606959413849
Reference: RGBX900H15
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation Travel Kit, 65W P/S, IN

IN1120135

Class IIaMDDOn the market

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959412934
Basic UDI-DI: B-00606959412934
Reference: IN1120135
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation Humidifier, Rental

RINXH

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959412286
Basic UDI-DI: B-00606959412286
Reference: RINXH
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation Auto CPAP w/Humid, GB Rent

RGBX500H15

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959411906
Basic UDI-DI: B-00606959411906
Reference: RGBX500H15
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation Humidifier, GB, Rental

RGBXH

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959410855
Basic UDI-DI: B-00606959410855
Reference: RGBXH
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation REMstar Humidifier GER, Rental

RDEXH

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959410831
Basic UDI-DI: B-00606959410831
Reference: RDEXH
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation BiPAP Auto Rental

RDEX700S13

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959410824
Basic UDI-DI: B-00606959410824
Reference: RDEX700S13
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation REMstar Auto Rental

RDEX500S13

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959410817
Basic UDI-DI: B-00606959410817
Reference: RDEX500S13
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation REMstar Pro Rental

RDEX400S13

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959410800
Basic UDI-DI: B-00606959410800
Reference: RDEX400S13
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DS2Adv Auto CPAP w/Humid/HT cell/BT, ND

NDX520T15C

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959075665
Basic UDI-DI: B-00606959075665
Reference: NDX520T15C
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation Auto FR Recert

UFRX500S14

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959069824
Basic UDI-DI: B-00606959069824
Reference: UFRX500S14
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DreamStation BiPAP S/T25, No Bluetooth, IN

INX1025H19

Class IIbMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959065758
Basic UDI-DI: B-00606959065758
Reference: INX1025H19
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DS2 CPAP w/Humid cell/BT, ES

ESX410H15C

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959063716
Basic UDI-DI: B-00606959063716
Reference: ESX410H15C
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DS2Adv CPAP w/Humid cell/BT, IT

ITX420H15C

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959063662
Basic UDI-DI: B-00606959063662
Reference: ITX420H15C
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DS2 CPAP w/Humid cell/BT, IT

ITX410H15C

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959063655
Basic UDI-DI: B-00606959063655
Reference: ITX410H15C
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

DS2Adv Auto CPAP w/Humid cell/BT, GB

GBX520H15C

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959063600
Basic UDI-DI: B-00606959063600
Reference: GBX520H15C
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 23:21

Manufacturer products Authorised representative products Authorised representative actors View details