- Role
- Country
- Date of registration
- Address
IT-MF-000008232KC45 Composite cushion with preformed base and self-modelling fluid inserts cm 48x45x8/6,5 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Capelli S.r.l.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 27, 2026
805901874FTCAG6Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08059018742619
The 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.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08059018742619Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
805901874FTCAG6KC454845UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
V08030102NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONSNo certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.805901874FTCAG6On the marketKC36 Compact viscoelastic cushion cm 43x43x4,5805901874FTCAG6On the marketKC36 Compact viscoelastic cushion cm 44x46x4,5805901874FTCAG6On the marketKC45 Composite cushion with preformed base and self-modelling fluid inserts cm 50x40x8/6,5805901874FTCAG6On the marketKC45 Composite cushion with preformed base and self-modelling fluid inserts 50x45x8/6,5805901874FTCAG6On the marketKC45 Composite cushion with preformed base and self-modelling fluid inserts cm 34x40x8/6,5805901874FTCAG6On the market