- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Feb 12, 2024
B-08033669101483BIB medical is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Eurosirel Spa. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08033669101483GIS101483(01)08033669101483
European Medical Device Nomenclature — the EU product classification assigned to this device.
M9001CRYOTHERAPY AND THERMOTHERAPY DEVICESPrimary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
IT-MF-0000059821648/MDDSterile
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 →8017990CNYGYOn the marketBiB feet - Paracalli ovali in lattice8017990PCLH6On the marketBiB feet - Paracalli tondi in lattice8017990PCLH6On the marketBM - 10 Bandas adhesivas plasticasB-08422414011625On the marketBM - 10 Tira adhesivas Agua8017990CMYGVOn the marketBM - 20 Tira adhesivas Infantiles8017990CMYGVOn the marketCertificate health across this manufacturer's portfolio.
293/MDRIssuedNotified 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 →No certificate specifically references this device's Basic UDI-DI.