- Role
- Country
- Date of registration
- Address
IT-MF-000011243No 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.LETTINO BOTTICELLI SKY PALENA is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by FERROX srl. 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 16, 2026
805347043BOTTICELLI8KPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08053470430657
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
LEGGERE LE ISTRUZIONI PRIMA DELL'USO
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.
08053470430657Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
805347043BOTTICELLI8K238000.11UDI 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.
Z12069099VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER805347043BOTTICELLI8KOn the marketLETTINO BOTTICELLI PRO 4 SEG., CON RUOTE, MANGO805347043BOTTICELLI8KOn the marketLETTINO BOTTICELLI PRO 4 SEG., CON RUOTE, NERO805347043BOTTICELLI8KOn the marketLETTINO BOTTICELLI TERRACOTTA805347043BOTTICELLI8KOn the marketLETTINO BOTTICELLI, ATOLL EVIDA805347043BOTTICELLI8KOn the marketLETTINO BOTTICELLI, BLU BALTIC805347043BOTTICELLI8KOn the marketNo certificate specifically references this device's Basic UDI-DI.