Papilocare Vaginal Gel

Organization name

Procare Health Iberia SL

SRN

ES-MF-000001950

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  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. Single use only, re-use may cause risk of cross-infection. 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. 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.

Primary placement in Italy; available across 4 countries total.

Trade name

Papilocare Vaginal Gel

UDI-DI code

08437018976133

Basic UDI-DI

8437018976PAPFQ

Reference / catalog number

NA

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

21

Additional product description

Vaginal Gel

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS