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FR-MF-0000117631434-MDD-420/2021Soluscope™ Serie 4 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Soluscope SAS. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 22, 2025
B-359766RMPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-359766RM
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
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 France; available across 21 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Sep 23, 2021 | Still on market |
| Belgium | Jul 12, 2024 | Still on market |
| Czechia | Mar 22, 2019 | Still on market |
| Germany | Jul 12, 2024 | Still on market |
| Estonia | Oct 31, 2017 | Still on market |
| EL | Sep 12, 2018 | Still on market |
| Spain | Jul 12, 2024 | Still on market |
| Finland | Jul 12, 2024 | Still on market |
| Croatia | Nov 5, 2024 | Still on market |
| Iceland | Jul 12, 2024 | Still on market |
| Italy | Jan 30, 2019 | Still on market |
| Lithuania | Jul 23, 2025 | Still on market |
| Latvia | Dec 12, 2018 | Still on market |
| Netherlands | Mar 29, 2021 | Still on market |
| Norway | Jul 12, 2024 | Still on market |
| Poland | Sep 2, 2019 | Still on market |
| Romania | Jul 12, 2024 | Still on market |
| Sweden | Jul 12, 2024 | Still on market |
| Slovenia | Jul 12, 2024 | Still on market |
| Slovakia | Jul 24, 2024 | Still on market |
| Türkiye | Jun 11, 2018 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-359766RMBasic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-359766RMSL-V4-PAUDI 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.
Z12011311ENDOSCOPE WASHERSNo certificate specifically references this device's Basic UDI-DI.
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.