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Organization name
UDI-DI code
Reference / catalog number

FTP070 — Class IIa MDD by Labomar S.p.A.

MD Atlas
Labomar S.p.A.

EUDAMED last updated this device on Apr 14, 2026

FTP070

B-FTP070ES

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Labomar S.p.A.
UDI-DI code: D-FTP070ES
Reference / catalog number: FTP070

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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 use the product if hypersensitive or allergic to any components. The use of the same bottle by several subjects can facilitate the transmission of infections: strictly personal use of the product is recommended. Do not use if the packaging is not intact. After use, clean and dry the dispenser. Keep out of reach of children. Do not use if the canister is damaged. Once the product is exhausted, do not pierce or burn the canister. Once used, discard the canister and the dispenser following the normal rules for separate disposal of municipal waste.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-FTP070ES
Basic UDI-DI: B-FTP070ES
Reference / catalog number: FTP070
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: Spray nasale ipertonico is a medical device intended for indicated for cleaning the stuffy nose and as adjuvant in the treatment of early cooling symptoms and in cases of sinusitis, rhinitis and rhinosinusitis in children, 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.

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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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