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EUDAMED last updated this device on Apr 25, 2024
8712175_TD_13_TOEBUDB7921 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Bevaplast B.V.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
087121759370067921(01)08712175937006
European Medical Device Nomenclature — the EU product classification assigned to this device.
V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER5 warnings recorded — scroll inside the panel to see all entries.
If you have diabetes or poor circulation, seek medical advice before using the product.
Discontinue use if wearing the toe separator is no longer comfortable. Keep the original packaging as it contains important information. Inform the manufacturer and the competent authority of any serious incidents. Keep out of reach of children.
If the skin becomes irritated, remove the toe spreader and stop using it. Get medical advice if symptoms persist or worsen.
Primary placement in Netherlands; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Sep 29, 2023 | Still on market |
| Germany | Sep 29, 2023 | Still on market |
NL-MF-000004386The 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.
Certificate health across this manufacturer's portfolio.
2265082CE01IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →