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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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DreamStation Humidifier FR

FRXH

Class IIaMDDOn the marketActive device

Manufacturer: Respironics Inc.
Manufacturer SRN: US-MF-000002301
UDI-DI: 00606959023628
Basic UDI-DI: B-00606959023628
Reference: FRXH
EMDN: R060201
EMDN description: ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,
First on market country: Germany
Authorised representative: Respironics Deutschland GmbH & Co.KG
Last updated: 01.08.2026 09:57

Manufacturer products Authorised representative products Authorised representative actors View details

InnoSpire Essence

InnoSpire Essence and InnoSpire Elegance

Class IIaMDDNo longer on the market

Manufacturer: Respironics Respiratory Drug Delivery (UK) Ltd
Manufacturer SRN: GB-MF-000002292
UDI-DI: 00383730001951
Basic UDI-DI: B-00383730001951
Reference: 1112261
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Cyprus
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 01.08.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

InnoSpire Essence

InnoSpire Essence and InnoSpire Elegance

Class IIaMDDNo longer on the market

Manufacturer: Respironics Respiratory Drug Delivery (UK) Ltd
Manufacturer SRN: GB-MF-000002292
UDI-DI: 00383730001890
Basic UDI-DI: B-00383730001890
Reference: 1099967
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Belgium
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 01.08.2026 09:54

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InnoSpire Elegance

InnoSpire Essence and InnoSpire Elegance

Class IIaMDDNo longer on the market

Manufacturer: Respironics Respiratory Drug Delivery (UK) Ltd
Manufacturer SRN: GB-MF-000002292
UDI-DI: 00383730001715
Basic UDI-DI: B-00383730001715
Reference: 1099973
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Belgium
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 01.08.2026 09:54

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InnoSpire Elegance

InnoSpire Essence and InnoSpire Elegance

Class IIaMDDNo longer on the market

Manufacturer: Respironics Respiratory Drug Delivery (UK) Ltd
Manufacturer SRN: GB-MF-000002292
UDI-DI: 00383730001692
Basic UDI-DI: B-00383730001692
Reference: 1099971
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Austria
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 01.08.2026 09:53

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NOVA PLUS

Class IIaMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: MEDTECH LIFE PRIVATE LIMITED
Manufacturer SRN: IN-MF-000020988
UDI-DI: 08906099800625
Basic UDI-DI: 890609980S0H10G7
Reference: S0H10
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

HANDYNEB NOVA

Class IIaMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: MEDTECH LIFE PRIVATE LIMITED
Manufacturer SRN: IN-MF-000020988
UDI-DI: 08906099800618
Basic UDI-DI: 890609980S0H9LQ
Reference: S0H9
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:23

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HANDYNEB PRO

Class IIaMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: MEDTECH LIFE PRIVATE LIMITED
Manufacturer SRN: IN-MF-000020988
UDI-DI: 08906099800595
Basic UDI-DI: 890609980S0H1L8
Reference: S0H1
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:23

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HANDYNEB MINI

Class IIaMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: MEDTECH LIFE PRIVATE LIMITED
Manufacturer SRN: IN-MF-000020988
UDI-DI: 08906099800571
Basic UDI-DI: 890609980S0H4LE
Reference: S0H4
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:23

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HANDYNEB PLUS

Class IIaMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: MEDTECH LIFE PRIVATE LIMITED
Manufacturer SRN: IN-MF-000020988
UDI-DI: 08906099800557
Basic UDI-DI: 890609980S0H23GG
Reference: S0H23
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:23

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HANDYNEB SUPER

Class IIaMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: MEDTECH LIFE PRIVATE LIMITED
Manufacturer SRN: IN-MF-000020988
UDI-DI: 08906099800540
Basic UDI-DI: 890609980S0H8LN
Reference: S0H8
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:23

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HANDYNEB SMART

Class IIaMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: MEDTECH LIFE PRIVATE LIMITED
Manufacturer SRN: IN-MF-000020988
UDI-DI: 08906099800533
Basic UDI-DI: 890609980S0H7LL
Reference: S0H7
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

HANDYNEB CLASSIC

Class IIaMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: MEDTECH LIFE PRIVATE LIMITED
Manufacturer SRN: IN-MF-000020988
UDI-DI: 08906099800526
Basic UDI-DI: 890609980S0H6LJ
Reference: S0H6
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

HANDYNEB SLIM

Class IIaMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: MEDTECH LIFE PRIVATE LIMITED
Manufacturer SRN: IN-MF-000020988
UDI-DI: 08906099800502
Basic UDI-DI: 890609980S0H3LC
Reference: S0H3
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:23

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HANDYNEB NUPRO

Class IIaMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: MEDTECH LIFE PRIVATE LIMITED
Manufacturer SRN: IN-MF-000020988
UDI-DI: 08906099800519
Basic UDI-DI: 890609980S0H5LG
Reference: S0H5
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Freevent XtraCare Mini Blue (30 pcs)

Freevent XtraCare

Class IMDR 2017/745On the marketSingle use

Manufacturer: Atos Medical AB
Manufacturer SRN: SE-MF-000000725
UDI-DI: 07331791014918
Basic UDI-DI: 7331791-HME-0-000-0004-XM
Reference: 8005
EMDN: R060299
EMDN description: HUMIDIFICATION SYSTEMS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 31.07.2026 22:01

Manufacturer products View details

HC1

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Hunan Beyond Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000002143
UDI-DI: 06958949917054
Basic UDI-DI: 6958949954JV
Reference: HC1
EMDN: R060280
EMDN description: HUMIDIFICATION SYSTEMS - ACCESSORIES
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

HM-HC01,HM-HC02,HM-HC03,HM-HC04,HM-HC05

Class IIaMDR 2017/745On the marketAdministering medicine

Manufacturer: Shenzhen Homed Medical Device Co., Ltd.
Manufacturer SRN: CN-MF-000016463
UDI-DI: 06956937005585
Basic UDI-DI: 69569370HOMED00006ZE
Reference: 06956937005585
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Türkiye
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Piston Compressor Nebulizer

Class IIaMDR 2017/745On the marketActive deviceAdministering medicineDirect marking

Manufacturer: Shenzhen Homed Medical Device Co., Ltd.
Manufacturer SRN: CN-MF-000016463
UDI-DI: 06956937001990
Basic UDI-DI: 69569370HOMED00001Z4
Reference: 06956937001990
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Türkiye
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

JLA series,JLB seriesJLC series,JLD series,JLE series,JLF series,JLG series,JLH series,JLI series,JLK series,JLL series,JLM series,JLO series,JLQ series

Class IIaMDR 2017/745On the marketAdministering medicineDirect markingSingle use

Manufacturer: Shenzhen Homed Medical Device Co., Ltd.
Manufacturer SRN: CN-MF-000016463
UDI-DI: 06956937000504
Basic UDI-DI: 69569370HOMED00005ZC
Reference: 06956937000504
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Türkiye
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details