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EUDAMED last updated this device on May 28, 2024
8712175_TD_09_STRXXLX7969 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.
040687060927637969(01)04068706092763
European Medical Device Nomenclature — the EU product classification assigned to this device.
M0599MEDICAL PLASTERS - OTHER4 warnings recorded — scroll inside the panel to see all entries.
Do not use the wound plaster if it is contaminated. The wound plaster should be replaced daily. Do not reuse the wound plaster as it can cause infection. Keep out of the reach of children. Store in the original packaging. It contains important information.
Stop using in the event of skin irritation or infection and consult a doctor if it persists.
Primary placement in Netherlands; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Jun 7, 2024 | Still on market |
| Germany | Jun 7, 2024 | 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 →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 →No certificate specifically references this device's Basic UDI-DI.