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EUDAMED last updated this device on Mar 5, 2025
8712175_TD_11_SPSUPFS8202 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.
087121759383178202(01)08712175938317
European Medical Device Nomenclature — the EU product classification assigned to this device.
M030499ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER2 warnings recorded — scroll inside the panel to see all entries.
ISO symbol
ISO symbol, For diabetes, sensory disorders of the skin, circulatory and lymphatic drainage disorders and skin diseases consult a doctor before use. Do not use the support in combination with other compression products, creams, skin oils, etc. In the event of tingling or numbness during the use, or white or violet colouring of the skin, remove the bandage immediately and check whether the correct size bandage is worn. Do not wear while sleeping or during prolonged resting periods. Discontinue use if skin irritation occurs and consult a doctor if this persists. Discontinue use if if the elasticity of the bandage decreases, the gel pad or the lateral stabilizers have been damaged. Store in the original packaging. This contains important information. Inform the manufacturer and the competent authority about serious incidents.
Primary placement in Netherlands; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Jun 28, 2024 | Still on market |
| Germany | Jun 28, 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 →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 →