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EUDAMED last updated this device on May 4, 2026
B-08437018976119Papilocare Vaginal Gel is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Procare Health Iberia SL. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08437018976119-(01)08437018976119
European Medical Device Nomenclature — the EU product classification assigned to this device.
U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS1 warning recorded — scroll inside the panel to see all entries.
If after application you experience discomfort, the use of the product should be discontinued, and the doctor consulted. No data are available on the use of Papilocare® with vaginal contraceptives (e.g., vaginal ring, female condom) so the use of Papilocare® in women who are using this type of contraceptive is not recommended. Do not use after expiry date on the packaging, the gel may have degraded and not perform as intended. Ensure cleaning between use to prevent contamination. Do not share applicator due to risk of cross-infection. Do not use the applicator if the measuring line is not clearly marked on it. Do not use if packaging or seal is compromised or if the product is damaged. Store only at the temperatures stated to avoid degradation of the gel. Do not use the applicator if you detect cracks in the plastic, sharp burrs on the part to be inserted in the vagina, or if the part is incomplete. Applicator shelf-life is 4 years. The applicator has no contraindications and no known side effects. Use the applicator only with Papilocare® vaginal gel and to measure only the amount indicated in this Instructions for Use (line marked at 3 ml). For HPV induced high-grade squamous intraepithelial lesions (HSIL), Papilocare® may be used only when conservative management is justified according to current clinical guidelines, and always under strict medical supervision. No overdose problems can be expected with the use of Papilocare®. However, there are no studies conducted considering this situation and it is recommended to be used only under strict medical supervision.
ES-MF-0000019501849/MDDPrimary placement in Spain; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
| France | — | Still on market |
| Portugal | — | 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 →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.B-08437018976492On the marketPapilocare Vaginal GelB-08437018976904On the marketPapilocare Vaginal Gel8437018976PAPFQOn the marketPapilocare Vaginal GelB-08437018976959On the marketPapilocare Vaginal GelB-08437018976553On the marketPapilocare Vaginal GelB-08437018976928On the marketNo certificate specifically references this device's Basic UDI-DI.