Manufacturer

Respironics

United StatesLegal entities : Respironics Inc.

Markets : Austria · Belgium · Bulgaria · Cyprus · Denmark · Estonia · France · Germany · Italy · Netherlands · Norway · Poland · Spain · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 176 · class I, II · latest in 2026 · see on the FDA website

EU representative : Respironics Deutschland GmbH & Co.KG (Germany)

eudamed@philips.com

20 categories, 775 models including 528 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Continuous positive pressure equipment	Z12030102	BiPAP Auto BiFlex, System One 60 Series, ES REMstar System (60 Series)93/42 BiPAP Disposable Circuit, Box/10 31210793/42 Dorma 500 Auto, w/ Humid, DE REMstar System (60 Series)93/42 DreamStation 2 Auto CPAP Advanced Humid/Cell/BT, ES93/42 DreamStation 2 Auto CPAP Advanced Humid/Cell/BT, IT93/42 272 others DreamStation 2 Auto CPAP Advanced Humid/P Flex/Cell/BT, FR FRX521H14C93/42 DreamStation 2 Auto CPAP Advanced Humidifier/Bluetooth® only, DE93/42 DreamStation 2 Auto CPAP Advanced w/ Humidifier/Cell/Bluetooth®, EE93/42 DreamStation 2 Auto CPAP Advanced w/ Humidifier/Cell/Bluetooth®, ND93/42 DreamStation 2 Auto CPAP Advanced w/Humidifier/Cell/Bluetooth, DE DreamStation 2 Advanced CPAP/Auto CPAP93/42 DreamStation 2 Auto CPAP Humid/Cell/BT, IT93/42 DreamStation 2 Auto CPAP w/ Humidifier/Cell/Bluetooth, EE DreamStation 2 CPAP/Auto CPAP93/42 DreamStation 2 CPAP Advanced Humid/BT only, EU93/42 DreamStation 2 CPAP Advanced Humid/Cell/BT, ES93/42 DreamStation 2 CPAP Advanced Humid/Cell/BT, GB93/42 DreamStation 2 CPAP AdvancedHumid/Cell/BT, EU93/42 DreamStation 2 CPAP w/ Humidifier/Cell/ Bluetooth, EE93/42 DreamStation 2 CPAP w/Humidifier/Bluetooth only, ES DreamStation 2 CPAP/Auto CPAP93/42 DreamStation Atuo CPAP w/Cell, ND NDX500S15C93/42 DREAMSTATION AUTO BIPAP W/HUMID Cell LA LAX700H15C93/42 DreamStation Auto BiPAP w/Humid, w/H Tube, AU AUX700T1593/42 DreamStation Auto BiPAP w/Humid, w/H Tube, INTL INX700T1593/42 DreamStation Auto BiPAP w/Humid, w/H Tube, LA LAX700T1593/42 DreamStation Auto BiPAP w/Humid, w/H Tube, w/Cell, AU AUX700T15C93/42 DreamStation Auto BiPAP with Humidifier, AR ARX700H1593/42 DreamStation Auto BiPAP with Humidifier, AU AUX700H1593/42 DreamStation Auto BiPAP with Humidifier, BL BLX700H1593/42 DreamStation Auto BiPAP with Humidifier, EE EEX700H1593/42 DreamStation Auto BiPAP with Humidifier, ES ESX700H1593/42 DreamStation Auto BiPAP with Humidifier, EU EUX700H1593/42 DreamStation Auto BiPAP with Humidifier, GB GBX700H1593/42 DreamStation Auto BiPAP with Humidifier, INTL INX700H1593/42 DreamStation Auto BiPAP with Humidifier, ND NDX700H1593/42 DreamStation Auto BiPAP with Humidifier, TR TRX700H1593/42 DreamStation Auto BiPAP, AR ARX700S1593/42 DreamStation Auto BiPAP, AU AUX700S1593/42 DreamStation Auto BiPAP, BL BLX700S1593/42 DreamStation Auto BiPAP, DE DEX700S1393/42 DreamStation Auto BiPAP, EE EEX700S1593/42 DreamStation Auto BiPAP, ES ESX700S1593/42 DreamStation Auto BiPAP, FR FRX700S1493/42 DreamStation Auto BiPAP, GB GBX700S1593/42 DreamStation Auto BiPAP, GB Rental RGBX700S1593/42 DreamStation Auto BiPAP, INTL INX700S1593/42 DreamStation Auto BiPAP, IT ITX700S1593/42 DreamStation Auto BiPAP, LA LAX700S1593/42 DreamStation Auto BiPAP, Latin America LAX700H1593/42 DreamStation Auto BiPAP, ND NDX700S1593/42 DreamStation Auto BiPAP, Ukraine UAX700S1593/42 DreamStation Auto BiPAP, US EUX700S1593/42 DreamStation Auto CPAP Cell, BL BLX500S15C93/42 DreamStation Auto CPAP Humidifier, Mediq BLX500H15MQ93/42 DreamStation Auto CPAP w/Cell ES ESX500S15C93/42 DreamStation Auto CPAP w/Humid w/H Tube, AU AUX500T1593/42 DreamStation Auto CPAP w/Humid w/H Tube, INTL INX500T1593/42 DreamStation Auto CPAP w/Humid w/H Tube, w/Cell, AU AUX500T15C93/42 DreamStation Auto CPAP w/Humid, GB Rent RGBX500H1593/42 DREAMSTATION AUTO CPAP W/HUMIDCell, LA LAX500H15C93/42 DREAMSTATION AUTO CPAP W/HUMIDIFIER Cell ARX500H15C93/42 DreamStation Auto CPAP w/Humidifier, w/Cell, Praxair, PT PTX500H15PRC93/42 DreamStation Auto CPAP w/Humidifier, w/H Tube, LA LAX500T1593/42 DreamStation Auto CPAP w/Humidifier, w/WiFi, IT ITX500H15W93/42 DreamStation Auto CPAP w/Humidifier, w/WiFi, Praxair, PT PTX500H15PRW93/42 DreamStation Auto CPAP w/Humidifier/Cell, BL BLX500H15C93/42 DreamStation Auto CPAP w/Humidifier/Cell, ND NDX500H15C93/42 DreamStation Auto CPAP w/ith Humidifier/Cell ES ESX500H15C93/42 DreamStation Auto CPAP w/WiFi, FR FRX500S14W93/42 DreamStation Auto CPAP with Humidifier, AR ARX500H1593/42 DreamStation Auto CPAP with Humidifier, AU AUX500H1593/42 DreamStation Auto CPAP with Humidifier, BL BLX500H1593/42 DreamStation Auto CPAP with Humidifier, EE EEX500H1593/42 DreamStation Auto CPAP with Humidifier, ES ESX500H1593/42 DreamStation Auto CPAP with Humidifier, EU EUX500H1593/42 DreamStation Auto CPAP with Humidifier, GB GBX500H1593/42 DreamStation Auto CPAP with Humidifier, INTL INX500H1593/42 DreamStation Auto CPAP with Humidifier, Latin America LAX500H1593/42 DreamStation Auto CPAP with Humidifier, ND NDX500S1593/42 DreamStation Auto CPAP with Humidifier, Praxair, PT PTX500H15PR93/42 DreamStation Auto CPAP with Humidifier, TR TRX500H1593/42 DreamStation Auto CPAP, AR ARX500S1593/42 DreamStation Auto CPAP, AU AUX500S1593/42 DreamStation Auto CPAP, BL BLX500S1593/42 DreamStation Auto CPAP, DE DEX500S1393/42 DreamStation Auto CPAP, EE EEX500S1593/42 DreamStation Auto CPAP, ES ESX500S1593/42 DreamStation Auto CPAP, EU EUX500S1593/42 DreamStation Auto CPAP, FR FRX500S1493/42 DreamStation Auto CPAP, GB GBX500S1593/42 DreamStation Auto CPAP, GB Rental RGBX500S1593/42 DreamStation Auto CPAP, IT ITX500S1593/42 DreamStation Auto CPAP, Latin America LAX500S1593/42 DreamStation Auto CPAP, ND NDX500H1593/42 DreamStation Auto CPAP, TR TRX500S1593/42 DreamStation Auto CPAP, Ukraine UAX500S1593/42 DreamStation Auto FR Recert UFRX500S1493/42 DreamStation autoSV with Humidifier, no Bluetooth, LA LAX900H1993/42 DreamStation AutoSV, Ukraine UAX900S1593/42 DreamStation BiPAP Auto Rental RDEX700S1393/42 DreamStation BiPAP autoSV , No Bluetooth, EU EUX900S1993/42 DreamStation BiPAP autoSV w/ Humid, DE Rental RDEX900H1393/42 DreamStation BiPAP autoSV w/ Humid, GB Rental RGBX900H1593/42 DreamStation BiPAP autoSV w/Humid w/H tube w/Cell, AU AUX900T15C93/42 DreamStation BiPAP autoSV w/humid w/h tube, no bluetooth, LA LAX900T1993/42 DreamStation BiPAP autoSV w/Humid, No Bluetooth, EU EUX900H1993/42 DreamStation BiPAP autoSV w/Humid, no Bluetooth, INTL INX900H1993/42 DreamStation BiPAP autoSV w/Humid, no Bluetooth, ZA ZAX900H1993/42 DreamStation BiPAP autoSV w/Humidifier, AU AUX900T1593/42 DreamStation BiPAP autoSV w/Humidifier, BL BLX900H1593/42 DreamStation BiPAP autoSV w/Humidifier, ES ESX900H1593/42 DreamStation BiPAP autoSV w/Humidifier, TR TRX900H1593/42 DreamStation BiPAP AutoSV with Humidifier, FR FRX900H1493/42 DreamStation BiPAP autoSV with Humidifier, ND NDX900H1593/42 DreamStation BiPAP autoSV with WiFi, FR FRX900S14W93/42 DreamStation BiPAP autoSV, AU AUX900S1593/42 DreamStation BiPAP autoSV, BL BLX900S1593/42 DreamStation BiPAP AutoSV, DE DEX900S1393/42 DreamStation BiPAP autoSV, DE Rental RDEX900S1393/42 DreamStation BiPAP AutoSV, EE EEX900S1593/42 DreamStation BiPAP autoSV, ES ESX900S1593/42 DreamStation BiPAP AutoSV, EU EUX900S1593/42 DreamStation BiPAP AutoSV, FR FRX900S1493/42 DreamStation BiPAP AutoSV, GB GBX900S1593/42 DreamStation BiPAP autoSV, GB Rental RGBX900S1593/42 DreamStation BiPAP AutoSV, IT ITX900S1593/42 DreamStation BiPAP autoSV, ND NDX900S1593/42 DreamStation BiPAP autoSV, no Bluetooth, INTL INX900S1993/42 Dreamstation BiPAP autoSV, no Bluetooth, LA LAX900S1993/42 DreamStation BiPAP autoSV, no Bluetooth, ZA ZAX900S1993/42 DreamStation BiPAP autoSV, TR TRX900S1593/42 DreamStation BiPAP autoSV, w/Hum w/HTube, no BT, INTL INX900T1993/42 DREAMSTATION BIPAP PRO W/HUMID Cell LA LAX600H15C93/42 DreamStation BiPAP Pro w/Humid w/H Tube, Latin America LAX600T1593/42 DreamStation BiPAP Pro w/Humidi w/H Tube, INTL INX600T1593/42 DreamStation BiPAP Pro with Humidifier, AR ARX600H1593/42 DreamStation BiPAP Pro with Humidifier, EU EUX600H1593/42 DreamStation BiPAP Pro with Humidifier, INTL INX600H1593/42 DreamStation BiPAP Pro with Humidifier, Latin America LAX600H1593/42 DreamStation BiPAP Pro with Humidifier, TR TRX600H1593/42 DreamStation BiPAP Pro, AR ARX600S1593/42 DreamStation BiPAP Pro, BL BLX600S1593/42 DreamStation BiPAP Pro, EU EUX600S1593/42 DreamStation BiPAP Pro, INTL INX600S1593/42 DreamStation BiPAP Pro, Latin America LAX600S1593/42 DREAMSTATION BIPAP PRO,Cell Modem, AR ARX600S15C93/42 DreamStation CPAP Pro Cell, BL BLX400S15C93/42 DreamStation CPAP Pro w/ Auto-Trial and Humidifier, AR ARX401H1593/42 DreamStation CPAP Pro w/ Auto-Trial and Humidifier, ES ESX401H1593/42 DreamStation CPAP Pro w/ Auto-Trial and Humidifier, EU EUX401H1593/42 DreamStation CPAP Pro w/ Auto-Trial, EU EUX401S1593/42 DreamStation CPAP Pro w/Cell ES ESX401S15C93/42 DREAMSTATION CPAP PRO W/HUMID Cell LA LAX400H15C93/42 DreamStation CPAP Pro w/Humid w/H Tube, INTL INX400T1593/42 DreamStation CPAP Pro w/Humid w/H Tube, LA LAX400T1593/42 DreamStation CPAP Pro w/Humid w/H Tube. w/Cell, AU AUX400T15C93/42 DreamStation CPAP Pro w/Humid w/Heated Tube, AU AUX400T1593/42 DreamStation CPAP Pro w/Humid, PW, 22mm PWX401H1593/42 DREAMSTATION CPAP PRO W/HUMIDIFIER, Cell ARX401H15C93/42 DreamStation CPAP Pro w/Humidifier, w/WiFi, IT ITX400H15W93/42 DreamStation CPAP Pro w/Humidifier/Cell, BL BLX400H15C93/42 DreamStation CPAP Pro with C Flex with Humidifier, GB GBX401H1593/42 DreamStation CPAP Pro with C-Flex, AR ARX401S1593/42 DreamStation CPAP Pro with C-Flex, ES ESX401S1593/42 DreamStation CPAP Pro with C-Flex, GB GBX401S1593/42 DreamStation CPAP Pro with Humidifier, AU AUX400H1593/42 DreamStation CPAP Pro with Humidifier, BL BLX400H1593/42 DreamStation CPAP Pro with Humidifier, EE EEX400H1593/42 DreamStation CPAP Pro with Humidifier, ES ESX400H1593/42 DreamStation CPAP Pro with Humidifier, EU EUX400H1593/42 DreamStation CPAP Pro with Humidifier, GB GBX400H1593/42 DreamStation CPAP Pro with Humidifier, INTL INX400H1593/42 DreamStation CPAP Pro with Humidifier, Latin America LAX400H1593/42 DreamStation CPAP Pro with Humidifier, TR TRX400H1593/42 DreamStation CPAP Pro with Humidifier/Cell ES ESX401H15C93/42 DreamStation CPAP Pro, AU AUX400S1593/42 DreamStation CPAP Pro, BL BLX400S1593/42 DreamStation CPAP Pro, DE DEX400S1393/42 DreamStation CPAP Pro, EE EEX400S1593/42 DreamStation CPAP Pro, ES ESX400S1593/42 DreamStation CPAP Pro, EU EUX400S1593/42 DreamStation CPAP Pro, FR FRX400S1493/42 DreamStation CPAP Pro, GB GBX400S1593/42 DreamStation CPAP Pro, INTL INX400S1593/42 DreamStation CPAP Pro, IT ITX400S1593/42 DreamStation CPAP Pro, Latin America LAX400S1593/42 DreamStation CPAP Pro, PW, 22mm PWX401S1593/42 DreamStation CPAP Pro, TR TRX400S1593/42 DreamStation CPAP Pro, Ukraine UAX400S1593/42 DreamStation CPAP w/ Humid/HT, LA LAX200T1593/42 DreamStation CPAP w/AHI ES ESX201S1593/42 DreamStation CPAP w/AHI, BL BLX201S1593/42 DreamStation CPAP w/AHI/Cell ES ESX201S15C93/42 DreamStation CPAP w/AHI/Cell, BL BLX201S15C93/42 DREAMSTATION CPAP W/HUMID,LA,Cell Modem, LAX200H15C93/42 DREAMSTATION CPAP W/HUMIDIFIER, Cell Mod ARX200H15C93/42 DreamStation CPAP w/Humidifier, w/Heated Tube, INTL INX200T1593/42 DreamStation CPAP with Humidifier, AR ARX200H1593/42 DreamStation CPAP with Humidifier, BL BLX200H1593/42 DreamStation CPAP with Humidifier, EU EUX200H1593/42 DreamStation CPAP with Humidifier, INTL INX200H1593/42 DreamStation CPAP with Humidifier, Latin America LAX200H1593/42 DreamStation CPAP with Humidifier, TR TRX200H1593/42 DreamStation CPAP, AR ARX200S1593/42 DreamStation CPAP, BL BLX200S1593/42 DreamStation CPAP, ES ESX200S1593/42 DreamStation CPAP, EU EUX200S1593/42 DreamStation CPAP, INTL INX200S1593/42 DreamStation CPAP, IT ITX200S1593/42 DreamStation CPAP, LA LAX200S1593/42 DreamStation CPAP, TR TRX200S1593/42 DreamStation Expert w/Humidifier, w/WiFi, FR FRX501H14W93/42 DreamStation Expert, FR FRX501S1493/42 DreamStation Flow Generator Cover 112816393/42 DreamStation REMstar Auto Rental RDEX500S1393/42 DreamStation REMstar Pro Rental RDEX400S1393/42 DreamStation Travel Kit, 65W P/S, AU AU112013593/42 DreamStation Travel Kit, 65W P/S, EU93/42 DreamStation Travel Kit, 65W P/S, IN IN112013593/42 DreamStation, BiPAP AutoSV with Humidifier, DE DEX900H1393/42 DreamStation, BiPAP AutoSV with Humidifier, EE EEX900H1593/42 DreamStation, BiPAP AutoSV with Humidifier, EU EUX900H1593/42 DreamStation, BiPAP AutoSV with Humidifier, GB GBX900H1593/42 DreamStation, BiPAP AutoSV with Humidifier, IT ITX900H1593/42 DREAMSTATIONAUTO BIPAP, AR+ Cell Modem, ARX700S15C93/42 DS2 Adv Auto CPAP w/Humid cell/BT, BL BLX520H15C93/42 DS2 Adv CPAP w/Humid cell/BT, BL BLX420H15C93/42 DS2 Auto CPAP w/Humid cell/BT, DE DEX420H13C93/42 DS2 CPAP w/Humid cell/BT, ES ESX410H15C93/42 DS2 CPAP w/Humid cell/BT, IT ITX410H15C93/42 DS2Adv Auto CPAP w/Humid BT only, EU EUX520H1593/42 DS2Adv Auto CPAP w/Humid cell/BT, EU EUX520H15C93/42 DS2Adv Auto CPAP w/Humid cell/BT, GB GBX520H15C93/42 DS2Adv Auto CPAP w/Humid/HT cell/BT, ND NDX520T15C93/42 DS2Adv CPAP w/Humid cell/BT, EE EEX420H15C93/42 DS2Adv CPAP w/Humid cell/BT, IT ITX420H15C93/42 Pressure Valve, 5 Pack 30242393/42 REMstar Pro C-Flex+, System One 60 Series, DE REMstar System (60 Series)93/42 Whisper Swivel II Packaged93/42 BiPAP Auto BiFlex System One 60 Series INT REMstar System (60 Series)93/42 (no longer marketed) BiPAP Auto BiFlex w/Humidifier System One 60 Series,GB REMstar System (60 Series)93/42 (no longer marketed) BiPAP Auto BiFlex, System One 60 Series, GB REMstar System (60 Series)93/42 (no longer marketed) BiPAP Auto BiFlex, System One, 60 Series, IT BiPAP Auto Bi-Flex93/42 (no longer marketed) BiPAP Auto BiFlex, w/HT Humid System One 60 Series, INTL REMstar System (60 Series)93/42 (no longer marketed) BiPAP Auto BiFlex, w/Humid System One 60 Series INT REMstar System (60 Series)93/42 (no longer marketed) BiPAP autoSV ADV 60 Series, 30cm DE BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE 60 Series, INTL BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE w/HT Humid, 60 Series, GER BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE w/HT Humid, 60 Series, INT BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE w/Humid, 60 Series INTL BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV SYS ONE w/Humid, 60 Series, GER BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV w/ HT Humid, 60 Series, 30cm INTL BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV, w/Humid 60 Series, 30cm, INTL BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP autoSV ADV,60 Srs, 30cm, DE Rental BiPAP autoSV Advanced System One93/42 (no longer marketed) BiPAP Pro BiFlex System One 60 Series INT REMstar System (60 Series)93/42 (no longer marketed) BiPAP Pro BiFlex, w/Humid System One 60 Series INT REMstar System (60 Series)93/42 (no longer marketed) DreamStation 2 Auto CPAP Humid/BT only, EU93/42 (no longer marketed) DreamStation 2 Auto CPAP Humid/BT only, IT93/42 (no longer marketed) DreamStation 2 Auto CPAP Humid/Cell/BT, ND93/42 (no longer marketed) DreamStation 2 Auto CPAP Humidifier/Cell/Bluetooth, EU DreamStation 2 CPAP/Auto CPAP93/42 (no longer marketed) DreamStation 2 CPAP Humid/BT only, EU93/42 (no longer marketed) DreamStation 2 CPAP Humid/BT only, IT93/42 (no longer marketed) REMstar Auto A-Flex System One 60 Series, Italy REMstar System (60 Series)93/42 (no longer marketed) REMstar Auto A-Flex, 60 Series, INTL REMstar System (60 Series)93/42 (no longer marketed) REMstar Auto A-Flex, System One 60 Series, GB REMstar System (60 Series)93/42 (no longer marketed) REMstar Auto A-Flex, System One 60 Series, Germany REMstar System (60 Series)93/42 (no longer marketed) REMstar Auto A-Flex, w/H Tube Humid, 60 Series, INTL REMstar System (60 Series)93/42 (no longer marketed) REMstar Auto A-Flex, w/Humid, System One 60 Srs, GB REMstar System (60 Series)93/42 (no longer marketed) REMstar Auto A-Flex, with Humidifier, 60 Series, INTL REMstar System (60 Series)93/42 (no longer marketed) REMstar Plus C-Flex, 60 Series, INTL REMstar System (60 Series)93/42 (no longer marketed) REMstar Plus C-Flex, w/H Tube Humid, 60 Series, INTL REMstar System (60 Series)93/42 (no longer marketed) REMstar Pro C-Flex+ w/SD Card, INT Rental REMstar Pro C-Flex+ CPAP System93/42 (no longer marketed) REMstar Pro C-Flex+, 60 Series, INTL REMstar System (60 Series)93/42 (no longer marketed) REMstar Pro C-Flex+, System One 60 Series, GB REMstar System (60 Series)93/42 (no longer marketed) REMstar Pro C-Flex+, System One 60 Series, Italy REMstar System (60 Series)93/42 (no longer marketed) REMstar Pro C-Flex+, w/HT Humid System One 60 Series INT93/42 (no longer marketed) REMstar Pro C-Flex+, w/Humid, System One 60 Srs,GB REMstar System (60 Series)93/42 (no longer marketed) REMstar Pro C-Flex+, with Humidifier, 60 Series, INTL REMstar System (60 Series)93/42 (no longer marketed) System One, Heated Tube System One Heated Humidifier SYS1HT1593/42 (no longer marketed)	IIa, IIb 93/42	EUDAMED record Report an error
Pulmonary ventilators for non-hospital use	Z12030103	(10) Bacterial/Viral Filter 113577693/42 (10) Circuit,Disp,15mm,Non-Htd,Dual Limb 112730793/42 (10) Circuit,Disp,22mm,Non-Htd,Active 113234493/42 (10) Circuit,Disp,22mm,Non-Htd,Dual Limb 112730693/42 (10) Disposable Active Exhalation Valve 113166193/42 246 others 4LXTB,6IN TRACH 15MM TAPER,CE 100496893/42 Active Exhalation Device Kit 106565993/42 Active Exhalation Device with PAP 105371693/42 Adult Invasive Passive Disposable Non-Heated Wire Circuit 106944393/42 Adult Non-Invasive Passive Disposable Non-Heated Circuit 106946793/42 BeLife 40 Pro SPX3100S1993/42 BiPAP A40 Pro AR ARX3100S1993/42 BiPAP A40 Pro BR BRX3100S1893/42 BiPAP A40 Pro Titration Rental Program AU RAUX3100S1993/42 BiPAP A40 Pro Titration Rental Program BL RBLX3100S1993/42 BiPAP A40 Pro Titration Rental Program BR RBRX3100S1993/42 BiPAP A40 Pro Titration Rental Program CA RCAX3100S1293/42 BiPAP A40 Pro Titration Rental Program DE RDEX3100S1393/42 BiPAP A40 Pro Titration Rental Program EE REEX3100S1993/42 BiPAP A40 Pro Titration Rental Program ES RESX3100S1993/42 BiPAP A40 Pro Titration Rental Program FR RFRX3100S1993/42 BiPAP A40 Pro Titration Rental Program GB RGBX3100S1993/42 BiPAP A40 Pro Titration Rental Program IN RINX3100S1993/42 BiPAP A40 Pro Titration Rental Program IT RITX3100S2193/42 BiPAP A40 Pro Titration Rental Program ND RNDX3100S1993/42 BiPAP A40 Pro, AU AUX3100S1993/42 BiPAP A40 Pro, BL BLX3100S1993/42 BiPAP A40 Pro, CA CAX3100S1293/42 BiPAP A40 Pro, CA w/Heated Tube Humid CAX3100T1293/42 BiPAP A40 Pro, DE DEX3100S1393/42 BiPAP A40 Pro, EE EEX3100S1993/42 BiPAP A40 Pro, ES ESX3100S1993/42 BiPAP A40 Pro, ES w/Heated Humidifier ESX3100H1993/42 BiPAP A40 Pro, ES w/Heated Tube Humid ESX3100T1993/42 BiPAP A40 Pro, FR FRX3100S1493/42 BiPAP A40 Pro, FR w/Heated Humidifier FRX3100H1493/42 BiPAP A40 Pro, FR w/Heated Tube Humid FRX3100T1493/42 BiPAP A40 Pro, IA IAX3100S1993/42 BiPAP A40 Pro, IA w/Heated Humidifier IAX3100H1993/42 BiPAP A40 Pro, IA w/Heated Tube Humid IAX3100T1993/42 BiPAP A40 Pro, Intl INX3100S1993/42 BiPAP A40 Pro, Intl w/Heated Humidifier INX3100H1993/42 BiPAP A40 Pro, Intl w/Heated Tube Humid INX3100T1993/42 BiPAP A40 Pro, IT ITX3100S2193/42 BiPAP A40 Pro, IT w/Heated Humidifier ITX3100H2193/42 BiPAP A40 Pro, IT w/Heated Tube Humid ITX3100T2193/42 BiPAP A40 Pro, ND NDX3100S1993/42 BiPAP A40 Pro, UK GBX3100S1993/42 BiPAP A40 Pro, UK w/Heated Humidifier GBX3100H1993/42 BiPAP A40 Pro, UK w/Heated Tube Humid GBX3100T1993/42 BiPAP A40 Sapio Belife93/42 Circuit Filter DEP w/FEP Filter Single, Intl 107394993/42 Circuit Filter DEP w/FEP Single, Intl 107394893/42 Circuit, DEP w/FEP, INTL, 10 Pack 106921093/42 Circuit, Disposable, 15mm, Non-Heated, Passive 113233993/42 Circuit, Disposable, 22mm, Adult, Non-Heated Passive 113234093/42 Disp Ext Flow Sensor,Adult/Ped, 10 pk 114649793/42 Disposable Adult Active Circuit no H20 Trap 20 pk 107323293/42 Disposable Adult Active Circuit no H2O Trap 107322393/42 Disposable Adult Passive Circuit no H20 Trap 20 pk 107323693/42 Disposable Adult Passve Circuit no H2O Trap 107322893/42 Disposable Ext Flow Sensor,Ped/Inf, 10pk 114655893/42 Disposable Pediatric Active Circuit with H20 Trap 20 pk 107322993/42 Disposable Pediatric Circuit with H20 Trap 107322093/42 Disposable Pediatric Passive Circuit with H20 Trap 20 pk 107323393/42 Disposable Pediatric Passive Circuit with H2O Trap 107322493/42 Disposable Swivel Passive Exhalation Port 113990993/42 DreamSt BiPAP AVAPS 30 AE w/HTD Humid, No Btooth, INTL INX1131H1993/42 DreamSt BiPAP AVAPS30 w/Humid, AAM,VitalAire,Vitalvent VTX1130H2493/42 DreamSt BiPAPAVAPS30, w/Humid MedicAir, RespiComfort MDX1130H2593/42 DreamStation AVAPS 25 w/Heated Humidifier, No Bluetooth, EU EUX1125H1993/42 DreamStation AVAPS 25 w/Hum,no Bluetooth, INTL INX1125H1993/42 DreamStation AVAPS 25 w/Humid w/H Tube, no Bluetooth, INTL INX1125T1993/42 DreamStation AVAPS 25, EU EUX1125S1593/42 DreamStation AVAPS 25, IT ITX1125S2193/42 DreamStation AVAPS 25, No Bluetooth, EU EUX1125S1993/42 DreamStation AVAPS 25, no Bluetooth, Intl INX1125S1993/42 DreamStation AVAPS 30 AAM ND NDX1130S1593/42 DreamStation AVAPS 30 AAM w/Hum,no Bluetooth, INTL INX1130H1993/42 DreamStation AVAPS 30 AAM, no Bluetooth, INTL INX1130S1993/42 DreamStation AVAPS 30 AE AAM w/Hum w/HTube, no BT, INTL INX1131T1993/42 DreamStation AVAPS 30 with Heated Humidifier, AAM ND NDX1130H1593/42 DreamStation AVAPS 30 with Heated Humidifier, ND NDX1130H2093/42 DreamStation AVAPS 30, ND NDX1130S2093/42 DreamStation AVAPS30 AAM, VT VTX1130S2493/42 DreamStation BiPAP AVAPS 30 AAM no Bluetooth, EU EUX1130S1993/42 DreamStation BiPAP AVAPS 30 AAM, ES ESX1130S1593/42 DreamStation BiPAP AVAPS 30 AAM, EU EUX1130S1593/42 DreamStation BiPAP AVAPS 30 AE No Bluetooth. INTL INX1131S1993/42 DreamStation BiPAP AVAPS 30 AE w/Humid w/H Tube, AU AUX1131T1593/42 DreamStation BiPAP AVAPS 30 AE, AU AUX1131S1593/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier AAM, FR FRX1130H1493/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM DE DEX1130H1393/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM EE EEX1130H2293/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM EU EUX1130H1593/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, EU EUX1125H1593/42 DreamStation BiPAP AVAPS 30 w/Heated Humidifier, GB GBX1130H2093/42 DreamStation BiPAP AVAPS 30 w/HTD Humid, No BT, EU EUX1130H1993/42 DreamStation BiPAP AVAPS 30 w/Hum w/HTube, No BT, INTL INX1130T1993/42 DreamStation BiPAP AVAPS 30, AAM w/ Humidifier, ES ESX1130H1593/42 DreamStation BiPAP AVAPS 30, GB GBX1130S2093/42 DreamStation BiPAP AVAPS 30, IT ITX1130S2193/42 DreamStation BiPAP AVAPS30 AAM BL BLX1130S1593/42 DreamStation BiPAP AVAPS30 AAM no Bluetooth, UA UAX1130S1993/42 DreamStation BiPAP AVAPS30 AAM w/Hum,no Bluetooth, ZA ZAX1130H1993/42 DreamStation BiPAP AVAPS30 AAM w/Humid, NO Bluetooth, UA UAX1130H1993/42 DreamStation BiPAP AVAPS30 AAM w/Humidifier, BL BLX1130H1593/42 DreamStation BiPAP AVAPS30 AAM w/Humidifier, TR TRX1130H1593/42 DreamStation BiPAP AVAPS30 AAM, EE EEX1130S2293/42 DreamStation BiPAP AVAPS30 AAM, FR FRX1130S1493/42 DreamStation BiPAP AVAPS30 AAM, Linde EOLUS LDX1130S2393/42 DreamStation BiPAP AVAPS30 AAM, MedicAir, Respi Comfort MDX1130S2593/42 DreamStation BiPAP AVAPS30 AAM, no Bluetooth, ZA ZAX1130S1993/42 DreamStation BiPAP AVAPS30 AAM, TR TRX1130S1593/42 DreamStation BiPAP AVAPS30 AAM, w/ Humidifier,Linde EOLUS LDX1130H2393/42 DreamStation BiPAP AVAPS30 AE AAM w/Humidifier, AU AUX1131H1593/42 DreamStation BiPAP AVAPS30 AE w/Cell, AU AUX1131S15C93/42 DreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/Cell, AU AUX1131T15C93/42 DreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/WiFi AU AUX1131T15W93/42 DreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell, AU AUX1131H15C93/42 DreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi, AU AUX1131H15W93/42 DreamStation BiPAP AVAPS30 AE w/WiFi, AU AUX1131S15W93/42 DreamStation BiPAP AVAPS30 with Humidifier, SP SPX1130H2193/42 DreamStation BiPAP AVAPS30, GB Rental RGBX1130S2093/42 DreamStation BiPAP AVAPS30, SP SPX1130S2193/42 DreamStation BiPAP S/T 25 w/ HTD Humid, No BT, EU EUX1025H1993/42 DreamStation BiPAP S/T 25 w/Heated Humidifier, EU EUX1025H1593/42 DreamStation BiPAP S/T 25, DE DEX1025S1393/42 DreamStation BiPAP S/T 25, EU EUX1025S1593/42 DreamStation BiPAP S/T 25, no Bluetooth, EU EUX1025S1993/42 DreamStation BiPAP S/T 30 AAM , No Bluetooth, EU EUX1030S1993/42 DreamStation BiPAP S/T 30 AAM w/Heated Humidifier, ES ESX1030H1593/42 DreamStation BiPAP S/T 30 AAM w/Heated Humidifier, EU EUX1030H1593/42 DreamStation BiPAP S/T 30 AAM, DE DEX1130S1393/42 DreamStation BiPAP S/T 30 AAM, EU EUX1030S1593/42 DreamStation BiPAP S/T 30 with Heated Humidifier, GB GBX1030H2093/42 DreamStation BiPAP S/T 30, GB GBX1030S2093/42 DreamStation BiPAP S/T ST30 AAM, ES ESX1030S1593/42 DreamStation BiPAP S/T25 w/Hum w/H Tube, no BT, INTL INX1025T1993/42 DreamStation BiPAP S/T25, No Bluetooth, IN INX1025H1993/42 DreamStation BiPAP S/T25, no Bluetooth, INTL INX1025S1993/42 DreamStation BiPAP S/T30 AAM BL BLX1030S1593/42 DreamStation BiPAP S/T30 AAM no Bluetooth, INTL INX1030S1993/42 DreamStation BiPAP S/T30 AAM TR TRX1030S1593/42 DreamStation BiPAP S/T30 AAM w/Hum w/HTube, no BT,INTL INX1030T1993/42 DreamStation BiPAP S/T30 AAM w/Hum, no Bluetooth, ZA ZAX1030H1993/42 DreamStation BiPAP S/T30 AAM w/Humidifier, BL BLX1030H1593/42 DreamStation BiPAP S/T30 AAM w/Humidifier, DE DEX1030H1393/42 DreamStation BiPAP S/T30 AAM w/Humidifier, TR TRX1030H1593/42 DreamStation BiPAP S/T30 AAM, DE DEX1030S1393/42 DreamStation BiPAP S/T30 AAM, no Bluetooth, ZA ZAX1030S1993/42 DreamStation BiPAP S/T30 w/ Humidifier, ES ESX1030H2093/42 DreamStation BiPAP S/T30 w/Hum,no Bluetooth,AAM INTL INX1030H1993/42 DreamStation BiPAP S/T30 with Humidifier, IT ITX1030H2093/42 DreamStation BiPAP S/T30, EE EEX1030S2293/42 DreamStation BiPAP S/T30, ES ESX1030S2093/42 DreamStation BiPAP S/T30, IT ITX1030S2093/42 DreamStation BiPAP ST30 AAM no Bluetooth, UA UAX1030S1993/42 DreamStation BiPAP ST30 AAM w/Humid, no Bluetooth, UA UAX1030H1993/42 DreamStation BiPAP Synchrony AVAPS AAM SAX1130S2793/42 DreamStation BiPAP Synchrony AVAPS AAM, with Humidifier SAX1130H2793/42 DreamStation S/T 30 w/Heated Humidifier, EE EEX1030H2293/42 DreamStation S/T 30 w/HTD Humid, No BT, AAM, EU EUX1030H1993/42 DreamStation ST 30 AAM, ND NDX1030S1593/42 DreamStation ST 30 with Heated Humidifier, AAM, ND NDX1030H1593/42 DreamStation ST 30 with Heated Humidifier, ND NDX1030H2093/42 DreamStation ST 30, ND NDX1030S2093/42 DreamStation, BiPAP S/T30, FR FRX1030S1493/42 Dual Limb Active Exhalation Valve 113211093/42 Dual Limb Active Exhalation Valve 113943693/42 External Flow Sensor Cable 113459293/42 External Flow Sensor w/Cable, Adult/Ped 113210693/42 External Flow Sensor w/Cable,Ped/Infant 113210793/42 External Flow Sensor, Adult/Ped 113471193/42 External Flow Sensor, Ped/Infant 113471293/42 FEP Circuit S/A W/O Filters 106921193/42 Filtered Exhalation Port (FEP) FPH 150PK 114061393/42 Filtered Exhalation Port (FEP) S/A, 150PK 113466493/42 Flex Trach Adapt 15cm,22M/15F-15 10pk 107386393/42 Flex Trach Adapt 15cm,22M/15F-22F10pk 107390293/42 Flex Trach Adapter 15cm, 22M/15F-15 20 pk 107390393/42 HOSE,22mm-18IN,NON-AUTOCLAV93/42 Kit, Active Exhalation Valve UPB 107545993/42 MPV Replacement Straw Kit 111884093/42 MPV Support System Kit 110286293/42 Oxygen O2 Enrichment Attachment 02 Enrichment Attachmnt Sngl93/42 Pediatric Invasive Passive Disposable Non-Heated Circuit 106944593/42 Rental, DreamStation ST30, GB RGBX1030S2093/42 Single Use Filtered Exhalation Port Circuit CKT FILTER DEP W/FEP 10PK INTL93/42 Trilogy 100 Ventilator,Germany-BT-RENT Trilogy 100, Trilogy EC93/42 Trilogy 200 Ventilator, Intl-Recert93/42 Trilogy Active Flow Exhalation Circuit, Pediatric 106883893/42 Trilogy Active with PAP Exhalation Circuit, Adult 105206493/42 Trilogy Active with PAP Exhalation Circuit, Pediatric 105206593/42 Trilogy Evo, Latin America LA2110X15B93/42 Trilogy Evo, O2, Latin America LA2100X15B93/42 Trilogy Evo, O2, Turkey TR2100X15B93/42 Trilogy Evo, Turkey TR2110X15B93/42 Trilogy Passive Exhalation Circuit, Adult 105206693/42 Trilogy Passive Exhalation Circuit, Pediatric 105212793/42 Trilogy, Mouthpiece Ventilation Disposable Circuit 110286693/42 Trilogy, Mouthpiece Ventilation Disposable Circuit 110286993/42 Trilovy EV300, O2 Australia AU2110X15B93/42 BiPAP A30 Ventilator France93/42 (no longer marketed) BiPAP A30 Ventilator Private Label, INTL93/42 (no longer marketed) BiPAP A30 Ventilator, INTL93/42 (no longer marketed) BiPAP A30, International-Rental2 refs93/42 (no longer marketed) BiPAP A30, Linde Eolus 3093/42 (no longer marketed) BiPAP A30, Medicair Respicomfort93/42 (no longer marketed) BiPAP A30, Silver Series- RENTAL93/42 (no longer marketed) BiPAP A30, Vitalaire Vitalvent 3093/42 (no longer marketed) BiPAP A30-S Silver Series93/42 (no longer marketed) BiPAP A30-S Silver Series - RENTAL93/42 (no longer marketed) BiPAP A40 Silver Series BiPAP A40 Ventilator93/42 (no longer marketed) BiPAP A40 Ventilator Private Label, INTL93/42 (no longer marketed) BiPAP A40 Ventilator, FR93/42 (no longer marketed) BiPAP A40 Ventilator, INTL93/42 (no longer marketed) BiPAP A40 Ventilator, IT93/42 (no longer marketed) BiPAP A40, International-Rental93/42 (no longer marketed) BiPAP A40, Silver Series - RENTAL93/42 (no longer marketed) Garbin Plus Ventilator, Bluetooth, INTL Trilogy 20093/42 (no longer marketed) Garbin Plus Ventilator, International93/42 (no longer marketed) Garbin Ventilator — Bluetooth93/42 (no longer marketed) Garbin Ventilator, Bluetooth, DE Trilogy 100, Trilogy EC93/42 (no longer marketed) Garbin Ventilator, DE Trilogy 100, Trilogy EC93/42 (no longer marketed) Garbin Ventilator, International Garbin Plus93/42 (no longer marketed) LifeVent200 Ventilator, Sapio, Bluetooth Trilogy 20093/42 (no longer marketed) Portable electric ventilator BiPAP A3093/42 (no longer marketed) Recert Trilogy 100 Ventilator,INTl - BT Trilogy 100, Trilogy EC93/42 (no longer marketed) Recert-Trilogy 100 Vent,Germany -BT Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy 100 Ventilator, INTL — Bluetooth Trilogy 100, Garbin93/42 (no longer marketed) Trilogy 100 Ventilator, INTL-BT-RENT Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy 20093/42 (no longer marketed) Trilogy 200 Ventilator, AERIS 200-BT93/42 (no longer marketed) Trilogy 200 Ventilator, Germany93/42 (no longer marketed) Trilogy 200 Ventilator, Germany-Recert93/42 (no longer marketed) Trilogy 200 Ventilator, Germany-Rental93/42 (no longer marketed) Trilogy 200 Ventilator, INTL-Bluetooth93/42 (no longer marketed) Trilogy 200 Ventilator, Intl-Rental93/42 (no longer marketed) Trilogy 200 Ventilator, Italy- BT93/42 (no longer marketed) Trilogy 202 Ventilator Germany Trilogy 202/O293/42 (no longer marketed) Trilogy 202 Ventilator International Trilogy 202/O293/42 (no longer marketed) Trilogy 202 Ventilator,Intl-RENTAL Trilogy 202/O293/42 (no longer marketed) Trilogy100 Ventilator, Bluetooth, Germany Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, Bluetooth, Italy Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, Germany Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, Germany-Recert Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, Germany-Rental Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, International Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, Intl-Recert Trilogy 100, Trilogy EC93/42 (no longer marketed) Trilogy100 Ventilator, Intl-Rental Trilogy 100, Trilogy EC93/42 (no longer marketed)	IIa, IIb 93/42	EUDAMED record Report an error
Portable pulmonary ventilators	Z12030104	Aeris EVO93/42 Circuit Filter DEP w/FEP Filter 10PK INTL Single Use Filtered Exhalation Port Circuit93/42 FEP Circuit S/A w/Filter – INTL Single Use Filtered Exhalation Port Circuit93/42 Garbin Evo, Linde93/42 LifeVentEVO293/42 51 others Trilogy EV300, Benelux93/42 Trilogy EV300, Eastern Europe93/42 Trilogy EV300, EU93/42 Trilogy EV300, EU (Non-BT)93/42 Trilogy EV300, France93/42 Trilogy EV300, Germany93/42 Trilogy EV300, Great Britain93/42 Trilogy EV300, INT w/ OBM93/42 Trilogy EV300, INTL93/42 Trilogy EV300, Italy93/42 Trilogy EV300, Nordics93/42 Trilogy EV300, Spain93/42 Trilogy EV300, Turkey93/42 Trilogy Evo O2, Benelux93/42 Trilogy Evo O2, Eastern Europe93/42 Trilogy Evo O2, France93/42 Trilogy Evo O2, Germany93/42 Trilogy Evo O2, Great Britain93/42 Trilogy Evo O2, Iberia93/42 Trilogy Evo O2, Italy93/42 Trilogy Evo O2, Nordics93/42 Trilogy Evo, Benelux93/42 Trilogy Evo, Eastern Europe93/42 Trilogy Evo, EU93/42 Trilogy Evo, EU (Non-BT)93/42 Trilogy Evo, France93/42 Trilogy Evo, Germany93/42 Trilogy Evo, Great Britain93/42 Trilogy Evo, Iberia93/42 Trilogy Evo, INT93/42 Trilogy Evo, International93/42 Trilogy Evo, International (Non-BT)93/42 Trilogy Evo, Italy93/42 Trilogy Evo, Nordics93/42 Trilogy Evo, O2, EU93/42 Trilogy Evo, O2, EU (Non-BT)93/42 Trilogy Evo, O2, INT93/42 Trilogy Evo, O2, International93/42 Trilogy Evo, O2, International (Non-BT)93/42 (10) BiPAP Disposable Humidifier Tubing 36 IN (91cm)93/42 (no longer marketed) (10) Disposable Proximal Pressure Line Assembly93/42 (no longer marketed) Disposable Proximal Pressure Line, 84 in (213.36 cm)93/42 (no longer marketed) Disposable Tubing 18 IN (46 cm)) QTY:10 BiPAP Disposable Circuits and Accessories93/42 (no longer marketed) Disposable Tubing 6 IN (15.2) QTY:10 BiPAP Disposable Circuits and Accessories93/42 (no longer marketed) Humidifier Tubing, 36 inch (91 cm) BiPAP Disposable Circuits and Accessories; Trilogy93/42 (no longer marketed) Trilogy 100 Ventilator, Germany Trilogy100 Ventilator Germany93/42 (no longer marketed) Trilogy 100 Ventilator, INTL — Bluetooth93/42 (no longer marketed) Trilogy 100 Ventilator, Italy - BT93/42 (no longer marketed) Trilogy 200 Ventilator Germany Bluetooth93/42 (no longer marketed) Trilogy 200 Ventilator, International93/42 (no longer marketed) Trilogy Evo, Medic Air93/42 (no longer marketed)	IIa, IIb 93/42	EUDAMED record Report an error
Various instruments for anaesthesia and pulmonary ventilation support - hardware accessories	Z1203019080	(10) Circuit, Disposable, 15mm, Non-Heated Trilogy Evo Accessories93/42 15MM Heated Tube HT1593/42 A40 Pro/EFL Detachable Battery Module, Rental3 refs Auto DC Cable Adapter3 refs DC Battery Adapter Cable3 refs 15 others DreamStation 2 Roll Stand DreamStation 4G Cell Modem w/ Ox, EU2 refs93/42 DreamStation Cell, Dipole, EU3 refs DreamStation Go Battery Pack DreamStation Roll Stand3 refs Li Ion Battery Case3 refs PRI Cellular Modem, EU Roll Stand, Trilogy Evo3 refs Shielded DC Cord SPRS-2 Roll Stand, 111 cm 114176593/42 Trilogy Remote Alarm Adapter Cable Trilogy Series Ventilator Accessories93/42 Z1203019080 DreamStation 4G Cell Modem w/ Ox, EU93/42 BiPAP A-Series Power Supply BiPAP A40 Ventilatory Accessory93/42 (no longer marketed) Portable Battery Pack (14.4AH)93/42 (no longer marketed) System One 60 Series Shielded DC Cord System One 60 Series Power Cables2 refs (no longer marketed)	I, IIa MDR, 93/42	EUDAMED record Report an error
Various instruments to support and monitor vital signs - medical device software	Z12039092	Care Orchestrator 112636693/42 Care Orchestrator Essence, Software - software 113570993/42 Care Orchestrator Essence, Software – finished good 113426993/42 DreamMapper App Android, APAC 112796093/42 DreamMapper App Android, China 113694793/42 3 others DreamMapper App iOS, China 113696893/42 DreamMapper Web, APAC 112793793/42 DreamMapper Web, China 113694693/42	I 93/42	EUDAMED record Report an error
Metabolic and physical activity holter systems	Z12040117	AW CT Angelini 152PO17433 Pkg Scorer93/42 AW CT Immusoft MT2018-18 Pkg Scorer93/42 AW CT Janssen 42847922MDD1005 Scorer93/42 AW CT Ultragenyx UX701-CL001 Pkg Scorer93/42 Actiware Clinical Trial Software, English - 693/42 (no longer marketed) 46 others Actiware Software CD - 693/42 (no longer marketed) Actiware Software Pkg., Addl License BOM93/42 (no longer marketed) Actiware Software Web Download - 693/42 (no longer marketed) Actiwatch Spectrum Device Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch Spectrum Plus-Recertified93/42 (no longer marketed) Actiwatch Spectrum Plus-Rental93/42 (no longer marketed) Actiwatch Spectrum PRO93/42 (no longer marketed) Actiwatch Spectrum PRO-Recertified93/42 (no longer marketed) Actiwatch Spectrum PRO-Rental93/42 (no longer marketed) AW CT Sanifit SNFCT2020-07 Scorer93/42 (no longer marketed) AW CT Sanifit SNFCT2020-07 Site93/42 (no longer marketed) AW CT Bayer 20887 Scorer93/42 (no longer marketed) AW CT Bayer 20887 Site93/42 (no longer marketed) AW CT Insmed INS 415 Pkg Scorer93/42 (no longer marketed) AW CT Insmed INS 415 Pkg Site93/42 (no longer marketed) AW CT Insmed INS 416 Pkg Scorer93/42 (no longer marketed) AW CT Insmed INS 416 Pkg Site93/42 (no longer marketed) AW CT Janssen 42756493BLC3001 Pkg Scorer93/42 (no longer marketed) AW CT Janssen 42847922MDD1005 Site93/42 (no longer marketed) AW CT Janssen 42847922MDD3001 Scorer93/42 (no longer marketed) AW CT Janssen 42847922MDD3001 Site93/42 (no longer marketed) AW CT Janssen CNTO1275CRD3007 Pkg Scorer93/42 (no longer marketed) AW CT Janssen NOPRODBIP0001 Pkg Scorer93/42 (no longer marketed) AW CT Kiniksa KPL-716-C001 Pkg Scorer93/42 (no longer marketed) AW CT Kiniksa KPL-OBS001 Pkg Scorer93/42 (no longer marketed) AW CT Koneksa Pkg LPS16677 Site93/42 (no longer marketed) AW CT MT-8554-E06 Pkg Scorer93/42 (no longer marketed) AW CT Novartis CAIN457FUS06 Pkg Scorer93/42 (no longer marketed) AW CT Ovid OV101-17-001 Pkg Scorer93/42 (no longer marketed) AW CT Ovid OV101-17-002 Pkg Scorer93/42 (no longer marketed) AW CT Regeneron R3500-AD-1798 Pkg Scorer93/42 (no longer marketed) AW CT Roche BP29937 Pkg Scorer93/42 (no longer marketed) AW CT TAK-994-1503 Scorer93/42 (no longer marketed) AW CT TAK-994-1503 Site93/42 (no longer marketed) AW CT Takeda TAK-925-2001 Pkg Scorer93/42 (no longer marketed) AW CT Takeda TAK-925-2001 Pkg Site93/42 (no longer marketed) AW CT Takeda TAK-925-2002 Pkg Scorer93/42 (no longer marketed) AW CT Takeda TAK-994-1501 Pkg Site93/42 (no longer marketed) AW CT Ultragenyx UX701-CL001 Pkg Site93/42 (no longer marketed) AW CT Vanda VP-VEC-162-3502 Pkg Scorer93/42 (no longer marketed) AW CT Vanda VP-VEC-162-3502 Pkg Site93/42 (no longer marketed) CT Sanofi LPS15497 Software Pkg Scorer-693/42 (no longer marketed) CT Sanofi LPS15497 Software Pkg Site93/42 (no longer marketed) CT XyloCor XC001-1001 SW Pkg Scorer93/42 (no longer marketed) Disposable Invasive Circuits93/42 (no longer marketed) Novartis Software PkgScorer93/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error
Adult pulmonary ventilators	Z1203010502	Dorma 200 w/Humid, INTL93/42 Dorma 200, INTL93/42 DreamStation Auto CPAP, INTL93/42 Dorma 100 IT93/42 (no longer marketed) Dorma 100 with Humidifier, INTL93/42 (no longer marketed) 17 others Dorma 100, INTL93/42 (no longer marketed) Dorma 100, Oxigen Salud93/42 (no longer marketed) Dorma 200 with Humidifier, FR93/42 (no longer marketed) Dorma 200 with SD Card, IT, con scheda SD, IT93/42 (no longer marketed) Dorma 200, FR93/42 (no longer marketed) Dorma 200, LD93/42 (no longer marketed) Dorma 200, with Humidifier, LD93/42 (no longer marketed) Dorma 400 w/Humid, DE93/42 (no longer marketed) Dorma 400, DE- RENTAL93/42 (no longer marketed) Dorma 500 Auto, IN93/42 (no longer marketed) Dorma 500 Auto, INTL93/42 (no longer marketed) Dorma 500 Auto, TR93/42 (no longer marketed) Dorma 500 Auto, with Humidifier, IN93/42 (no longer marketed) Dorma 500 Auto, with Humidifier, INTL93/42 (no longer marketed) Dorma 500 Auto, with Humidifier, TR93/42 (no longer marketed) REMstar SE with Heated Tube, with SD Slot, INTL93/42 (no longer marketed) REMstar SE with HUMIDIFIER, with SD Slot, INTL93/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error
Polysomnography instruments - software accessories	Z12100582	Sleepware G3 Software Package_English 108246293/42 Sleepware G3 Software Package_ML 108246393/42 Software, Sleepware G3, Web 111572093/42	IIa 93/42	EUDAMED record Report an error
Various pneumology and respiratory physiopathology instruments - software accessories	Z12159082	OmniLab Connect System OmniLab Direct Software (ML) 111203393/42 OmniLab Direct Software (Web) 111312793/42	I, IIb MDR, 93/42	EUDAMED record Report an error
Oxygen concentrators	Z12159004	SimplyGo External Battery Module2 refs SimplyGo Mini Extended Battery Kit2 refs ULTRAFILL,230V,EU93/42 (no longer marketed)	I, IIb MDR, 93/42	EUDAMED record Report an error
Positional biofeedback systems	Z12062402	Philips NightBalance, Refurbishment Kit, DK93/42 NightBalance93/42 (no longer marketed) Philips Basic Kit, PerformaTrak SE, INTL PerformaTrak SE Disposable Full Face Mask93/42 (no longer marketed) Philips NightBalance DK93/42 (no longer marketed) Philips NightBalance Mobile App, Android93/42 (no longer marketed) 12 others Philips NightBalance Mobile App, iOS93/42 (no longer marketed) Philips NightBalance NL93/42 (no longer marketed) Philips NightBalance UK93/42 (no longer marketed) Philips NightBalance, DE93/42 (no longer marketed) Philips NightBalance, FR93/42 (no longer marketed) Philips NightBalance, IB93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, Canada93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, DE93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, FR93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, NL93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, UK93/42 (no longer marketed) Philips NightBalance,Refurbishment Kit,IB93/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error
Adult and paediatric/neonatal pulmonary ventilators	Z1203010504	CoughAssist E70 Accessories CA70 SERIES,CIRCUIT,ADULT LG.,6FT93/42	IIb 93/42	EUDAMED record Report an error
Spirometry instruments - hardware accessories	Z12150180	Trilogy Active Flow Exhalation Circuit Adult Trilogy Circuit Accessories93/42	IIa 93/42	EUDAMED record Report an error
Various instruments for anaesthesia and pulmonary ventilation support - other	Z1203019099	BiPAP A40 In-Use Case	I MDR	EUDAMED record Report an error
Polysomnographs No model still on the market	Z12100501	"Alice PDx ECG Yoke Cable, Intl "93/42 (no longer marketed) Alice 5 International Base Unit Only 101723093/42 (no longer marketed) Alice 5 International Headbox 101723193/42 (no longer marketed) Alice LE System INTL Alice 5 and Alice LE Polysomnography Systems93/42 (no longer marketed) Alice Night One, Wireless, Ukraine93/42 (no longer marketed) 16 others Alice NightOne Non-Wireless, Warranty, INTL93/42 (no longer marketed) Alice NightOne System Intl, Wireless, Rental93/42 (no longer marketed) Alice NightOne Wireless Device, INTL93/42 (no longer marketed) Alice NightOne Wireless, Warranty ,INTL93/42 (no longer marketed) Alice NightOne, Non-Wireless Device, INTL93/42 (no longer marketed) Alice NightOne, Wireless, Masimo, INTL93/42 (no longer marketed) Alice PDx Core System without Sensors, INTL93/42 (no longer marketed) ALICE PDx Diagnostic System International, Rental93/42 (no longer marketed) Alice PDx ECG Yoke, INTL93/42 (no longer marketed) Alice PDx ExG Yoke, INTL93/42 (no longer marketed) ALICE PDX Portable Sleep Diagnostic System International93/42 (no longer marketed) Alice PDx Sleep Diagnostic System, INTL93/42 (no longer marketed) Alice PDx Unit Only, Warranty Exchange, INTL93/42 (no longer marketed) Cable, ExG Yoke, Alice PDx, Intl. Rental93/42 (no longer marketed) Recert, Alice NightOne Intl93/42 (no longer marketed) Recert, Alice NightOne Intl Wireless93/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error
Kinematic motion capture analysis systems - other No model still on the market	Z12062599	Actical Software93/42 (no longer marketed) Actical-Recertified93/42 (no longer marketed) Actical-Rental93/42 (no longer marketed) Actiwatch 2 Communication Dock Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch 2 Communication Dock System Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) 13 others Actiwatch 2 Communication Dock System Recertified Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch 2 Communication Dock System Rental Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch 2 Device Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch 2 Device Recertified Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch 2 Device-Rental Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch 2 System Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch Spectrum Communication Dock Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch Spectrum Communication Dock System Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch Spectrum Communication Dock System Recertified Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch Spectrum Communication Dock System Rental Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch Spectrum Device Recertified Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch Spectrum Device Rental Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) ActiWatch Spectrum System Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error
Polysomnography instruments - hardware accessories No model still on the market	Z12100580	AIR FLOW,CANNULA SAMPLE PACK P125893/42 (no longer marketed) Alice 6 Therapy Circuit Interface Kit93/42 (no longer marketed) Cable, Low Level Output, 3/32" (2.381 mm) Male Phone Connector93/42 (no longer marketed) CPAP Titration Kit, Alice PDx Pro-Tech Sensors Wire Sets and Accessories93/42 (no longer marketed) Double Port CPAP Titration Kit93/42 (no longer marketed) 5 others NK Piezo Sensor93/42 (no longer marketed) PIEZO 1 CH PEDIATRIC KIT93/42 (no longer marketed) zRIP Cable Abdomen, QDC93/42 (no longer marketed) zRIP DuraBelt Kit, Adult, QDC93/42 (no longer marketed) zRIP DuraBelt Kit, Ped., QDC93/42 (no longer marketed)	I 93/42	EUDAMED record Report an error
Ultrasonic nebulisers No model still on the market	Z12040210	InnoSpire Go EU1/ROW93/42 (no longer marketed) InnoSpire Go EU2/ROW93/42 (no longer marketed) InnoSpire Go LiteTouch Large Mask93/42 (no longer marketed) InnoSpire Go LiteTouch Medium Mask93/42 (no longer marketed) InnoSpire Go LiteTouch Small Mask93/42 (no longer marketed) 2 others InnoSpire Go Mask Adapter93/42 (no longer marketed) InnoSpire Go UK/INT93/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error
Bioimaging processors No model still on the market	Z11069001	EncoreBasic Compliance Reporting System93/42 (no longer marketed) EncorePro2 Patient Management Software93/42 (no longer marketed) Software, EncorePro2, Web EncorePro2 Patient Management Software93/42 (no longer marketed) Web, DirectView Software DirectView PC Software Application (no longer marketed)	I MDR, 93/42	EUDAMED record Report an error
Polysomnography instruments - medical device software No model still on the market	Z12100592	PC Direct Software93/42 (no longer marketed)	IIb 93/42	EUDAMED record Report an error

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