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Organization name
UDI-DI code
Reference / catalog number

Benylin 150 ml UK, IRL — Class IIa MDR by Labomar S.p.A.

MD Atlas
Labomar S.p.A.

EUDAMED last updated this device on Apr 21, 2026

Benylin 150 ml UK, IRL

805630062FTPR101DK

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Labomar S.p.A.
UDI-DI code: 08056300621904
Reference / catalog number: FTPR101

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View device family (Basic UDI)

Manufacturer information

Organization name: Labomar S.p.A.
SRN: IT-MF-000007965
Manufacturer status: Active

Related devices

FTP035B-FTP035_1JLOn the market FTP089B-FTP089_1LBOn the market FTPR101805630062FTPR101DKOn the market FTPR101805630062FTPR101DKOn the market FTPR101805630062FTPR101DKOn the market

Certificates

Certificate health across this manufacturer's portfolio.

CSQ0026240424Supplemented
Quality management systemNotified body: 0373Expiry: Oct 27, 2029

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Do not administer the product to children under two years of age. In children aged two years, if symptoms persist and worsen after first two days of treatment, consult your doctor. If you do not notice appreciable results after a short period of treatment (7 days), contact your doctor, in any case do not use for more than 15 days. Do not take it if you are allergic, intolerant or hypersensitive to any component. Do not use the product after the expiry date printed on the package. Keep out of the reach of children. Do not use for purposes other than that for which the product is intended. If you or your child experiences side effects, inform your doctor. Expiry date refers to the product in its intact packaging, and properly stored. Since no data on use in pregnancy and breastfeeding are available, its use is not recommended. If you are pregnant or breastfeeding, consult a doctor before use. Do not use in case the package is not intact. The period of validity after the first opening of the syrup is 3 months. Any serious incident that occurs in relation to the device should be reported to the manufacturer and the Competent Authority. In case of any undesired event always seek for medical advice.

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Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: Benylin 150 ml UK, IRL
UDI-DI code: 08056300621904
Basic UDI-DI: 805630062FTPR101DK
Reference / catalog number: FTPR101
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Benylin is a medical device composed of substances, not sterile, intended for short term invasive contact with respect to body orifices (oral cavity), designed for the treatment of productive and dry cough in children (2+), adolescents and adults.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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