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IT-MF-000021280Sens'o'Roll is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by LEDRAPLASTIC SPA. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Feb 15, 2023
8001698F2D04M1I1P015UPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08001698088068
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
2 warnings recorded — scroll inside the panel to see all entries.
OTHER
OTHER
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 32 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | 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.
08001698088068Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
8001698F2D04M1I1P015U88.06UDI 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.
V0899MEDICAL SUPPORT EQUIPMENT - OTHER8001698F4D04M1I2P068BOn the marketReflexball Set 88001698F4D04M1I2P068BOn the marketReflexball Set 98001698F4D04M1I2P068BOn the marketSit’n’Gym 55 BRQ8001698F1D03M2I1P024ROn the marketSit’n’Gym 65 BRQ8001698F1D03M2I1P024ROn the marketSit’n’Gym Jr. 358001698F1D03M1I1P024COn the marketNo 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.No certificate specifically references this device's Basic UDI-DI.