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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

FTP054 — Class IIb MDD by Labomar S.p.A.

MD Atlas
Labomar S.p.A.

EUDAMED last updated this device on Apr 14, 2026

FTP054

B-FTP054_108J

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Labomar S.p.A.
UDI-DI code: D-FTP054_108J
Reference / catalog number: FTP054

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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
• Keep out of reach of children • Even if no side effects are known, it is recommended not to use the product during pregnancy or breastfeeding and in children under 12 years of age. In any case, consult your doctor before taking it. • Do not exceed the dosage of 4 tablets a day • Do not take if you are allergic or hypersensitive to any component. • Do not use the product after the expiry date printed on the package. • The expiry date refers to the product in intact package, properly stored.

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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-FTP054_108J
Basic UDI-DI: B-FTP054_108J
Reference / catalog number: FTP054
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: Medical device indicated for the treatment of the irritable bowel syndrome, characterized by pain, swelling, distension and abdominal discomfort, associated or not with changes in the appearance of faeces and intestinal irregularity (constipation, diarrhea or alternation of both).
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.

G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS

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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