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95541002443030

CDH 340, CDH 350, CDH 450, & CDH 500

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Star Medik Sdn. Bhd.
Manufacturer SRN: MY-MF-000025171
UDI-DI: 95541002443030
Basic UDI-DI: 95541002443CDHUD
Reference: TF-CDH-003/09
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:20

Manufacturer products Authorised representative products Authorised representative actors View details

COMFORT HI-FLOW

CF10

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: SEOIL PACIFIC CORP.
Manufacturer SRN: KR-MF-000012478
UDI-DI: 08809517012016
Basic UDI-DI: 951701ComfortHiFlowEB
Reference: H20000
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: Spain
Authorised representative: Advena Limited
Last updated: 04.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

F&P 950

Respiratory Humidifier

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Fisher & Paykel Healthcare Limited
Manufacturer SRN: NZ-MF-000002556
UDI-DI: 09420012455420
Basic UDI-DI: 94200124950RHH001S6
Reference: 950AEU
EMDN: R060201
EMDN description: ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,
First on market country: Germany
Authorised representative: FISHER & PAYKEL HEALTHCARE SAS
Last updated: 04.07.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

iSmart

nice 8050, nice 8010

Class IIaMDR 2017/745Not intended for EU marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989204
Basic UDI-DI: 8908003989nice8050M4
Reference: nice 8050
EMDN: R060201
EMDN description: ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 03.07.2026 22:05

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OxyPAP

nice 5060, nice 5060 S, nice 5060 F

Class IIbMDR 2017/745Not intended for EU marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989037
Basic UDI-DI: 8908003989nice5060LJ
Reference: nice 5060
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 03.07.2026 22:05

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Pulmospray

Pulmospray MDR

Class IIaMDR 2017/745On the marketAdministering medicineSingle use

Manufacturer: Resyca B.V.
Manufacturer SRN: NL-MF-000010950
UDI-DI: 08720865413006
Basic UDI-DI: 8720865413MD-18646AB
Reference: SG-44281
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 20:06

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NEBULIZER SET NEWBORN

NEBULIZER SET

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: TMS MEDİKAL PLASTİK ÜRÜNLERİ SANAYİ VE DIŞ TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000019237
UDI-DI: 86988638301280
Basic UDI-DI: 869886383NEB3F
Reference: T20161
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:50

Manufacturer products View details

Aerogen Nebulizer Cable

Class IMDR 2017/745On the market

Manufacturer: METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000022486
UDI-DI: 08698870376275
Basic UDI-DI: 86988703AECARGXXNEBCBLMD
Reference: AEC-ARG/GE
EMDN: R0680
EMDN description: NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:50

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Reusable Humidifier Heater Wire Adapter

Class IMDR 2017/745On the market

Manufacturer: METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000022486
UDI-DI: 08698870357625
Basic UDI-DI: 86988703HWAXHWAXSOCPG6
Reference: HWA-001
EMDN: R060280
EMDN description: HUMIDIFICATION SYSTEMS - ACCESSORIES
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:50

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08695476080803

Corensis CC-150

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: BIÇAKÇILAR TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000022603
UDI-DI: 08695476080803
Basic UDI-DI: 86954760RD0101NQ
Reference: RC0102
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:43

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08695476080155

Corensis Oxymax

Class IIbMDR 2017/745On the marketActive deviceReusable

Manufacturer: BIÇAKÇILAR TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000022603
UDI-DI: 08695476080155
Basic UDI-DI: 86840320RD0101BQ
Reference: RD0101
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:20

Manufacturer products View details

Humidifier Bottle for Oxygen Concentrator

Non-Sterile Humidifier Bottle for Oxygen Concentrator

Class IIaMDR 2017/745On the marketDirect markingSingle use

Manufacturer: DEJAVU MEDİKAL SAN VE TİC.LTD.ŞTİ
Manufacturer SRN: TR-MF-000044720
UDI-DI: 08682858945652
Basic UDI-DI: 868285894OKSK001B3
Reference: DJ2747
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 03.07.2026 18:07

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Nebura

Class IIaMDR 2017/745On the marketActive deviceAdministering medicineDirect marking

Manufacturer: Lainomedical, S.L.
Manufacturer SRN: ES-MF-000036750
UDI-DI: 08437024920014
Basic UDI-DI: 8437024920N017G
Reference: N01
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:14

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INHALADOR RESPIRATOR

Class IMDR 2017/745On the market

Manufacturer: JOSE MESTRE S.A.
Manufacturer SRN: ES-MF-000008198
UDI-DI: 08435058400618
Basic UDI-DI: 8435058C00IRP0001DSF6
Reference: 0000003306
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:42

Manufacturer products View details

FL-X FLUSSIMETRO UNI O2

Flowmeter

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Spencer Italia s.r.l.
Manufacturer SRN: IT-MF-000027507
UDI-DI: 08057711235537
Basic UDI-DI: 805771123FLOWMETERSGA
Reference: FL08320
EMDN: R0699
EMDN description: NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:47

Manufacturer products View details

FL-X FLUSSIMETRO C/UMID. UNI O2

Flowmeter with humidifier

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Spencer Italia s.r.l.
Manufacturer SRN: IT-MF-000027507
UDI-DI: 08057711235483
Basic UDI-DI: 805771123FLOWMETERGROUP4J
Reference: FL08314
EMDN: R0699
EMDN description: NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:47

Manufacturer products View details

08056590238073

CURAMED CHAMBERNEB

Class IMDR 2017/745On the marketAdministering medicineDirect marking

Manufacturer: CURA FARMA SRL
Manufacturer SRN: IT-MF-000011478
UDI-DI: 08056590238073
Basic UDI-DI: 80565902380734Z
Reference: 26234
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:19

Manufacturer products View details

CURAMED UMIDIFCATORE BOTTIGLIA

CURAMED GORGOGLIATORE

Class IMDR 2017/745On the marketAdministering medicineSingle use

Manufacturer: CURA FARMA SRL
Manufacturer SRN: IT-MF-000011478
UDI-DI: 08056590239728
Basic UDI-DI: 80565902325369TK
Reference: 25369
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:16

Manufacturer products View details

CURAMED RHINONEB

Class IMDR 2017/745On the marketAdministering medicineDirect marking

Manufacturer: CURA FARMA SRL
Manufacturer SRN: IT-MF-000011478
UDI-DI: 08055305950231
Basic UDI-DI: 8055305950231ZG
Reference: 26235
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 10:30

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DuoBaby Nebulizer Accessory set (NEB2012)

Accessories for aerosoltherapy equipment

Class IIaMDR 2017/745On the market

Manufacturer: 3A HEALTH CARE S.r.l.
Manufacturer SRN: IT-MF-000009298
UDI-DI: 04015672110656
Basic UDI-DI: 803371701NEB6204244
Reference: NEB2012
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:08

Manufacturer products View details