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EUDAMED last updated this device on Jul 24, 2026
803360952GASTRICBANDX8BYBAND is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by MED EUROPE EUROPEAN MEDICAL SUPPLIES SRL. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08033609524181BB 05-07 L1 packaging level registered — each level carries its own UDI-DI.
08033609524181× 1 unitBase unit08033609528745× 30 units(01)08033609524181
European Medical Device Nomenclature — the EU product classification assigned to this device.
G020501GASTRIC BANDS5 warnings recorded — scroll inside the panel to see all entries.
Il prodotto deve essere utilizzato immediatamente dopo l’apertura della confezione. Una volta aperto il prodotto, esaminarlo attentamente: non utilizzarlo in caso si riscontrino difetti. Non modificare in alcun modo il prodotto. Danni involontari al corpo del prodotto causati da lame o aghi possono ridurre notevolmente la forza tensile del dispositivo; prestare quindi molta attenzione durante l’inserimento ed evitarne l’utilizzo in caso di involontaria perforazione/taglio. Lo slippage è una condizione possibile che si può verificare.
Primary placement in Italy; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
| Romania | — | Still on market |
IT-MF-000026962ITI 2522914 1The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
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 →Certificate health across this manufacturer's portfolio.
ITI 2522914 1IssuedNotified 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.
ITH 2522914 1IssuedNotified 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.
ITH 2522914 1IssuedNotified 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.
0425-MDR-030102-01AmendedNotified 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.
0425-MDR-030028-02IssuedNotified 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.
0425-MDR-030029-02IssuedNotified 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 →