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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

FTP048 — Class IIb MDD by Labomar S.p.A.

MD Atlas
Labomar S.p.A.

EUDAMED last updated this device on Apr 13, 2026

FTP048

B-FTP048_1KA

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Labomar S.p.A.
UDI-DI code: D-FTP048_1KA
Reference / catalog number: FTP048

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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 administer more than 2 suppositories a day. Do not use in case of allergy or hypersensitivity to any component. Do not use after the expiry date reported on the package. The expiry date refers to the product properly stored in unopened package. Keep out of the reach of children. Do not use in case the package is open or damaged. Do not swallow. Interrupt the treatment in case of abnormal reactions. Natural substances that compose the device make it coloured therefore, after the application, pay particular attention not to stain your clothing.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-FTP048_1KA
Basic UDI-DI: B-FTP048_1KA
Reference / catalog number: FTP048
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: PROCTO-ZAC RELIEF is a medical device for the treatment of hemorrhoidal disorders, proctitis, anal fissures, it reduces the pain, burning and itching.
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.

G05TOPICAL ANORECTAL ADMINISTERED GASTRO-INTESTINAL SYSTEM DEVICES

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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