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EUDAMED last updated this device on Mar 6, 2026
5904335216zel/dopX4ELANEE Vaginal-Gel is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by LABORATOIRE L'IDEAL Parisien Sp. z o.o.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04260018197482ELANEE Vaginal-Gel 7 applicators DE, EN, FR, IT(01)04260018197482
European Medical Device Nomenclature — the EU product classification assigned to this device.
U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS7 warnings recorded — scroll inside the panel to see all entries.
During pregnancy and breastfeeding, use only after consulting your doctor or pharmacist.
Do not use the product if the applicator is damaged
● When using the product in patients with severe vaginal dryness, due to the lactic acid content of the product, slight reactions may occur at the site of application (mild burning or itching). These symptoms are temporary and usually disappear spontaneously. If the symptoms persist, this may indicate hypersensitivity to the ingredients of the product. In this case, discontinue use of the product and consult your doctor or pharmacist.
• If vaginal dryness persists, consult your doctor or pharmacist
PL-MF-000005402The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
• Avoid accidental contact of the gel with the mucous membranes of the eyes, nose or mouth.
Store at temperatures between 15 °C and 25 °C in the original packaging.
OTHER
Primary placement in Germany; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
| France | — | Still on market |
| Italy | — | Still on market |
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 →B-05903678429843On the marketE PRO SKINOTOPIQ MED KREM DO CIAŁAB-05904335216370On the marketE PRO SKINOTOPIQ MED KREM DO CIAŁAB-05904335216363On the marketELANEE Vaginal-Ovula5904335216globul/dopELOn the marketfabÜ Hello HealingB-07331898173563On the marketfabÜ Hello JoyB-07331898173556On the marketNo 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.No certificate specifically references this device's Basic UDI-DI.