- Role
- Country
- Date of registration
- Address
DK-MF-000014646Turn All Leva Flex System 3CT is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Levabo ApS. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 19, 2026
5711014turnallLBPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05711014701610
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 Denmark; available across 21 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Jan 1, 2021 | Still on market |
| Austria | Jan 1, 2021 | Still on market |
| Belgium | Jan 1, 2021 | Still on market |
| Bulgaria | Jan 1, 2021 | Still on market |
| Cyprus | Jan 1, 2021 | Still on market |
| Germany | Jan 1, 2021 | Still on market |
| EL | Jan 1, 2021 | Still on market |
| Spain | Jan 1, 2021 | Still on market |
| Finland | Jan 1, 2021 | Still on market |
| France | Jan 1, 2021 | Still on market |
| Ireland | Jan 1, 2021 | Still on market |
| Iceland | Jan 1, 2021 | Still on market |
| Italy | Jan 1, 2021 | Still on market |
| Netherlands | Jan 1, 2021 | Still on market |
| Norway | Jan 1, 2021 | Still on market |
| Poland | Jan 1, 2021 | Still on market |
| Portugal | Jan 1, 2021 | Still on market |
| Romania | Jan 1, 2021 | Still on market |
| Sweden | Jan 1, 2021 | Still on market |
| Slovenia | Jan 1, 2021 | Still on market |
| Türkiye | Jan 1, 2021 | 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.
05711014701610Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
5711014turnallLB70161UDI 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.
V080702NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSESNo 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.5711014turnallLBOn the marketTurn All Bariatic Mattress5711014turnallLBOn the marketTurn All Cover TPU5711014turnallLBOn the marketTurn All Mattres5711014turnallLBOn the marketTurn All System 1CT5711014turnallLBOn the marketTurn All System 1CT 30CR5711014turnallLBOn the marketNo certificate specifically references this device's Basic UDI-DI.