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Bebicina

Sterile hypertonic solution of sodium chloride 3% in vials for inhalation

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratoire Unither
Manufacturer SRN: FR-MF-000004062
UDI-DI: D-5400951000626RH
Basic UDI-DI: B-5400951000626RH
Reference: 5 400951 000626
EMDN: R0699
EMDN description: NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 17.07.2026 02:46

Manufacturer products View details

RINOPURE

Sterile isotonic solution of sodium chloride 0.9% in single-dose vial for eye and nasal cleansing, ear rinsing, wound cleansing and inhalation

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratoire Unither
Manufacturer SRN: FR-MF-000004062
UDI-DI: D-5202888106217WU
Basic UDI-DI: B-5202888106217WU
Reference: 5 202888 106217
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Greece
Authorised representative: -
Last updated: 17.07.2026 02:36

Manufacturer products View details

KNOXZY® 7%

Sterile hypertonic solution of sodium chloride 7% in vials for inhalation

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratoire Unither
Manufacturer SRN: FR-MF-000004062
UDI-DI: D-5065007265147UE
Basic UDI-DI: B-5065007265147UE
Reference: 5 065007 265147
EMDN: R0699
EMDN description: NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 17.07.2026 02:34

Manufacturer products View details

KNOXZY® 6%

Sterile hypertonic solution of sodium chloride 6% in vials for inhalation

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratoire Unither
Manufacturer SRN: FR-MF-000004062
UDI-DI: D-5065007265130TV
Basic UDI-DI: B-5065007265130TV
Reference: 5 065007 265130
EMDN: R0699
EMDN description: NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 17.07.2026 02:34

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Bronchlear 6%

Sterile hypertonic solution of sodium chloride 6% in vials for inhalation

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratoire Unither
Manufacturer SRN: FR-MF-000004062
UDI-DI: D-5060611190748S5
Basic UDI-DI: B-5060611190748S5
Reference: 5 060611 190748
EMDN: R0699
EMDN description: NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 17.07.2026 02:28

Manufacturer products View details

Bronchlear 3%

Sterile hypertonic solution of sodium chloride 3% in vials for inhalation

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratoire Unither
Manufacturer SRN: FR-MF-000004062
UDI-DI: D-5060611190731RL
Basic UDI-DI: B-5060611190731RL
Reference: 5 060611 190731
EMDN: R0699
EMDN description: NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 17.07.2026 02:28

Manufacturer products View details

Nebusal® 7% Accord

Sterile hypertonic solution of sodium chloride 7% in vials for inhalation

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratoire Unither
Manufacturer SRN: FR-MF-000004062
UDI-DI: D-50555657700472R
Basic UDI-DI: B-50555657700472R
Reference: 5 055565 770047
EMDN: R0699
EMDN description: NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 17.07.2026 02:18

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ALVITA®

Sterile isotonic solution of sodium chloride 0.9% in single-dose vial for eye and nasal cleansing, ear rinsing, wound cleansing and inhalation

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratoire Unither
Manufacturer SRN: FR-MF-000004062
UDI-DI: D-5055382317357X8
Basic UDI-DI: B-5055382317357X8
Reference: 5 055382 317357
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 02:18

Manufacturer products View details

ALVITA®

Sterile isotonic solution of sodium chloride 0.9% in single-dose vial for eye and nasal cleansing, ear rinsing, wound cleansing and inhalation

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratoire Unither
Manufacturer SRN: FR-MF-000004062
UDI-DI: D-5055382317234WP
Basic UDI-DI: B-5055382317234WP
Reference: 5 055382 317234
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Norway
Authorised representative: -
Last updated: 17.07.2026 02:18

Manufacturer products View details

ALVITA®

Sterile isotonic solution of sodium chloride 0.9% in single-dose vial for eye and nasal cleansing, ear rinsing, wound cleansing and inhalation

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratoire Unither
Manufacturer SRN: FR-MF-000004062
UDI-DI: D-5055382309741XG
Basic UDI-DI: B-5055382309741XG
Reference: 5 055382 309741
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Romania
Authorised representative: -
Last updated: 17.07.2026 02:18

Manufacturer products View details

ALVITA®

Sterile isotonic solution of sodium chloride 0.9% in single-dose vial for eye and nasal cleansing, ear rinsing, wound cleansing and inhalation

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratoire Unither
Manufacturer SRN: FR-MF-000004062
UDI-DI: D-5055382303541VU
Basic UDI-DI: B-5055382303541VU
Reference: 5 055382 303541
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Türkiye
Authorised representative: -
Last updated: 17.07.2026 02:18

Manufacturer products View details

ALVITA®

Sterile isotonic solution of sodium chloride 0.9% in single-dose vial for eye and nasal cleansing, ear rinsing, wound cleansing and inhalation

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratoire Unither
Manufacturer SRN: FR-MF-000004062
UDI-DI: D-5055382303527W2
Basic UDI-DI: B-5055382303527W2
Reference: 5 055382 303527
EMDN: R060203
EMDN description: INHALATION THERAPY HUMIDIFICATION LIQUIDS
First on market country: Türkiye
Authorised representative: -
Last updated: 17.07.2026 02:18

Manufacturer products View details

HUMID VENT MINI

IPN929801

Class IIaMDDOn the marketSingle use

Manufacturer: Teleflex Medical Sdn. Bhd.
Manufacturer SRN: MY-MF-000024692
UDI-DI: 14026704929464
Basic UDI-DI: B-14026704929464
Reference: 10012
EMDN: R060299
EMDN description: HUMIDIFICATION SYSTEMS - OTHER
First on market country: Ireland
Authorised representative: Teleflex Medical
Last updated: 17.07.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

F&P 850

MR290VX

Class IIaMDDOn the marketSingle use

Manufacturer: Fisher & Paykel Healthcare Limited
Manufacturer SRN: NZ-MF-000002556
UDI-DI: 09420012466877
Basic UDI-DI: B-09420012466877
Reference: MR290VX
EMDN: R060280
EMDN description: HUMIDIFICATION SYSTEMS - ACCESSORIES
First on market country: Sweden
Authorised representative: FISHER & PAYKEL HEALTHCARE SAS
Last updated: 17.07.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

Nebulizer Mask

GT012-100

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Ningbo Greetmed Medical Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000009634
UDI-DI: 06958627540130
Basic UDI-DI: B-06958627540130
Reference: GT012-100 XL
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Greece
Authorised representative: MedPath GmbH
Last updated: 16.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

Microlife

BR-CN116

Class IIaMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: ShenZhen Bi-rich Medical Devices Co., Ltd
Manufacturer SRN: CN-MF-000023061
UDI-DI: 06975070916183
Basic UDI-DI: 697507091CNZN
Reference: NEB310(p957310-4)
EMDN: R060101
EMDN description: COLD NEBULISATION SYSTEMS
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 11:14

Manufacturer products Authorised representative products Authorised representative actors View details

Humidification Chamber

YM-A060

Class IMDR 2017/745Not intended for EU marketSingle use

Manufacturer: Ningbo Yingmed Medical Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000002183
UDI-DI: 06974580757903
Basic UDI-DI: 697458075A060GK
Reference: YM-A060
EMDN: R060280
EMDN description: HUMIDIFICATION SYSTEMS - ACCESSORIES
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

Humidifier Bottle

YM-A046

Class IMDR 2017/745Not intended for EU marketSingle use

Manufacturer: Ningbo Yingmed Medical Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000002183
UDI-DI: 06974580757880
Basic UDI-DI: 697458075A046GR
Reference: YM-A046
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

“T” accesorio para Nebualdo Easy Pro(Aldo-Union)

Class IIaNot specifiedOn the market

Manufacturer: Vapo Healthcare Co., Ltd.
Manufacturer SRN: CN-MF-000014728
UDI-DI: 06970979578395
Basic UDI-DI: 697097957NebTP8T
Reference: Neb TP5
EMDN: R0680
EMDN description: NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: Spain
Authorised representative: Share info GmbH
Last updated: 16.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Mesh Nebulizer Cup

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Vapo Healthcare Co., Ltd.
Manufacturer SRN: CN-MF-000014728
UDI-DI: 06970979578371
Basic UDI-DI: 697097957VP-MHXG
Reference: VP-MH7
EMDN: R0680
EMDN description: NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 16.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details