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FR-MF-00001222131393DENTASEPT SH PRO is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by D.M.D.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Nov 13, 2025
B-03597610626401Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)03597610626401
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 15 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
| Austria | Apr 9, 2021 | Still on market |
| Bulgaria | Apr 9, 2021 | Still on market |
| Czechia | Aug 22, 2022 | Still on market |
| Germany | Apr 9, 2021 | Still on market |
| Estonia | May 26, 2023 | Still on market |
| Croatia | Oct 31, 2023 | Still on market |
| Hungary | Apr 9, 2021 | Still on market |
| Ireland | Apr 9, 2021 | Still on market |
| Lithuania | May 26, 2023 | Still on market |
| Latvia | Apr 9, 2021 | Still on market |
| Poland | May 26, 2023 | Still on market |
| Romania | Apr 9, 2021 | Still on market |
| Slovenia | Apr 9, 2021 | Still on market |
| Slovakia | Jul 15, 2024 | 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.
03597610626401Basic 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-035976106264012462326AOUDI 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.
D0901AMMONIUM SALTS FOR THE DISINFECTION OF MEDICAL DEVICESNo 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.B-03597610626449On the marketDENTASEPT ASPIRATION AF+B-03597610627170On the marketDENTASEPT ASPIRATION AF+B-03597610627187On the marketDENTASEPT SH PROB-03597610626876On the marketDENTASEPT SH PROB-03597610626418On the marketDENTASEPT SH PRO WIPESB-03597610639777On the marketNo certificate specifically references this device's Basic UDI-DI.