- Role
- Country
- Date of registration
- Address
FR-MF-00001222131390No 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.Dentasept Spray 60 pro is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. 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 May 7, 2025
B-03597610627132Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)03597610627132
4 warnings recorded — scroll inside the panel to see all entries.
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 23 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
| Austria | May 21, 2021 | Still on market |
| Belgium | May 21, 2021 | Still on market |
| Bulgaria | May 21, 2021 | Still on market |
| Czechia | Aug 22, 2022 | Still on market |
| Germany | May 21, 2021 | Still on market |
| Denmark | Sep 20, 2023 | Still on market |
| Estonia | May 26, 2023 | Still on market |
| EL | Aug 17, 2022 | Still on market |
| Spain | Jun 20, 2024 | Still on market |
| Finland | Sep 20, 2023 | Still on market |
| Hungary | May 21, 2021 | Still on market |
| Italy | Sep 6, 2016 | Still on market |
| Lithuania | May 26, 2023 | Still on market |
| Latvia | Jun 27, 2022 | Still on market |
| Netherlands | May 21, 2021 | Still on market |
| Norway | Sep 20, 2023 | Still on market |
| Poland | May 26, 2023 | Still on market |
| Portugal | May 25, 2022 | Still on market |
| Romania | May 21, 2021 | Still on market |
| Sweden | Sep 20, 2023 | Still on market |
| Slovenia | May 21, 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.
03597610627132Basic 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-035976106271322475042BOUDI 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 DEVICESB-03597610629778On the marketDentasept Spray 60 proB-03597610627156On the marketDentasept Spray 60 proB-03597610627149On the marketDentasept Spray 60 ProB-03597610627163On the marketDENTASEPT TRI ENZYMATICB-03597610627217On the marketDENTASEPT TRI ENZYMATICB-03597610641138On the marketNo certificate specifically references this device's Basic UDI-DI.