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EUDAMED last updated this device on Apr 14, 2026
B-FTP054_5K5Kaleidon IBS ES, PT is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Labomar S.p.A.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-FTP054_5K5FTP054D-FTP054_5K5
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS1 warning recorded — scroll inside the panel to see all entries.
OTHER
Primary placement in Spain; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
| Portugal | — | Still on market |
IT-MF-000007965 EPT 0477.MDD.19/3160.4Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →805630062FTPR169FOn the marketJuanola tos spray bucal sabor miel mentolada ES805630062FTPR1297On the marketKaleidon IBS 60 cpr GRB-FTP091F2On the marketKRAMEGIN LAVANDA 5 100 ml ITB-FTP089FFOn the marketKruidvat (Keelspray / Vaporisateur pour la gorge / Rachenspray) NL/BE805630062FTPR1297On the marketKruidvat Hoestdrank 2 in 1 120 mL BE805630062FTPR449LOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
EPT 0477.MDR.25/5971.1ReissuedEPT 0477.MDR.23/5173.2ReissuedEPT 0477.MDR.26/6216IssuedCSQ0026240724SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →