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EUDAMED last updated this device on Feb 29, 2024
8712175_TD_02_STRCOEP6053 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.
087191793308026053(01)08719179330802
European Medical Device Nomenclature — the EU product classification assigned to this device.
M04040301HYDROCOLLOID DRESSINGS, NON-COMBINED6 warnings recorded — scroll inside the panel to see all entries.
Consult a doctor before using if suffering from diabetes or poor blood circulation.
Do not puncture a blister, as this can cause infections. Do not use on a bleeding blister or on skin or blister that is infected. Do not use the blister plaster if it is contaminated, or if the sterile packaging is damaged or has been opened accidentally. Failure to apply the plaster according to the instructions may cause skin damage (e.g. by the plaster curling up). Stop using in the event of skin irritation or infection and consult a doctor if it persists. Do not reuse the blister plaster as this can cause infection. Keep out of reach of children.
Primary placement in Netherlands; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Jan 12, 2024 | Still on market |
| Belgium | Jan 12, 2024 | Still on market |
NL-MF-0000043862265082CE01The 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.