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EUDAMED last updated this device on Apr 17, 2026
5715841043306MFAKKMono Plus PU 88x200x14 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by ZiboCare A/S. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05715841501764MONOP88B(01)05715841501764
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y99DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - OTHER1 warning recorded — scroll inside the panel to see all entries.
Primary placement in Denmark; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Feb 20, 2023 | Still on market |
DK-MF-000045317The 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.
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 →No certificate specifically references this device's Basic UDI-DI.
5715841043306MFLWOn the marketMono Plus PU 83x200x145715841043306MFAKKOn the marketMono Plus PU 85x200x145715841043306MFAKKOn the marketMono PU 100x200x145715841043306MFAKKOn the marketMono PU 105x200x145715841043306MFAKKOn the marketMono PU 110x200x145715841043306MFAKKOn 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.