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Organization name
UDI-DI code
Reference / catalog number

GRANIONS® SPRAY GORGE FR — Class IIa MDD by Labomar S.p.A.

MD Atlas
Labomar S.p.A.

EUDAMED last updated this device on Apr 20, 2026

GRANIONS® SPRAY GORGE FR

B-FTP098FG

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Labomar S.p.A.
UDI-DI code: D-FTP098FG
Reference / catalog number: FTP098

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View device family (Basic UDI)

Manufacturer information

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

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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 take if hypersensitive or allergic to one of the components: - Do not use the product after the expiration date on the package; - Keep out of children's reach; - Shake the vial before use; - The period of validity after the first use is 3 months (12 weeks); - The use of the same vial by several subjects can facilitate the transmission of infections: strictly personal use of the product is recommended; - Wash and dry carefully the dispenser before and after use; - Do not use in case the packaging is not intact; - Do not administer to children under 3 years of age; - 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; - So far, no side effects have been observed as a result of the administration of the device. However, if you notice the appearance of side effects, inform your doctor or pharmacist; - The expiry date refers to the packaged product intact, properly stored.

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Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: GRANIONS® SPRAY GORGE FR
UDI-DI code: D-FTP098FG
Basic UDI-DI: B-FTP098FG
Reference / catalog number: FTP098
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: GRANIONS® SPRAY GORGE is a medical device composed of substances, non-sterile, intended for short term invasive contact with respect to body orifices (oral cavity), designed for the treatment of dry and wet cough and sore throat. Gorgewell spray intended for adult and children above 3 years of age.
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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