- Role
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EUDAMED last updated this device on May 23, 2023
42519522BevistoSeptplus2CBevistoSept plus Wipes 12 x Nachfüllbeutel mit je 120 Tüchern is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by BEVISTON GmbH. Placed on the EU market in Croatia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
DE-MF-000015203(01)04251952220916
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
6 warnings recorded — scroll inside the panel to see all entries.
OTHER
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.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Croatia; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| CroatiaPrimary placement | Nov 11, 2021 | May 23, 2023 |
| Bulgaria | Apr 29, 2022 | May 23, 2023 |
| Czechia | Jun 16, 2022 | May 23, 2023 |
| Germany | Feb 11, 2022 | May 23, 2023 |
| EL | Nov 19, 2021 | May 23, 2023 |
| France | Nov 15, 2021 | May 23, 2023 |
| Lithuania | Jan 31, 2022 | May 23, 2023 |
| Romania | Jun 9, 2022 | May 23, 2023 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
04251952220916Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
42519522BevistoSeptplus2C2091UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
D0701ETHANOL FOR THE DISINFECTION OF MEDICAL DEVICESPrimary 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 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.42519522BevistoSeptplus2COn the marketBevistoSept plus 5 Liter Kanister42519522BevistoSeptplus2COn the marketBevistoSept plus Wipes 12 x Dose mit je 120 Tüchern42519522BevistoSeptplus2COn the marketBevistoSept plus Wipes Dose mit 120 Tüchern42519522BevistoSeptplus2COn the marketBevistoSept plus Wipes Nachfüllbeutel mit 120 Tüchern42519522BevistoSeptplus2COn the marketBevistoTray Cleaner 1 Liter Flasche42519522BevistoTray7XOn the marketNo certificate specifically references this device's Basic UDI-DI.