MEDCARE Rectal suppositories with sodium hyaluronate

Organization name

LABORATOIRE L'IDEAL Parisien Sp. z o.o.

SRN

PL-MF-000005402

Manufacturer status

Active

7 warnings recorded — scroll inside the panel to see all entries.

• Ask your pharmacist or doctor for advice before using or taking the product (e.g. if pregnant or breastfeeding)

  Due to the lack of complete data, it is not recommended to use the product during pregnancy, unless it is absolutely necessary and under the direct supervision of a doctor supervising the pregnancy. If you experience heavy bleeding in advanced stages of haemorrhoids, occurring independently of bowel movements, you should contact your doctor. The use of the product in this situation is subject to the doctor's decision.

• Do not use if package is damaged

  Do not use the product if the outer packaging has been damaged before first use. Do not use the product if the immediate packaging is damaged.

• If any symptoms are troublesome or last more than a few days or if you notice any side effects not mentioned, please inform your doctor or pharmacist

  If symptoms persist or worsen after using the product, consult your doctor.

• P102 – Keep out of reach of children.

  Keep the product out of the reach of children

• P103 – Read label before use.

  Before using the product, read the instructions for use, as they contain important information for the patient regarding the use of the product. Keep the instructions for use so that you can read them again if necessary

• • Do not use the product in children. Medical device for rectal use in adults. • The product is intended for rectal use only. Do not swallow! • The product is not intended for use in combination with other rectal products or rectal medicines. Do not use with other rectal products or rectal medicines

  OTHER

• Do not use past indicated date

  Do not use the medical device after the expiry date stated on the packaging.

Primary placement in Poland; available across 1 country total.

Trade name

MEDCARE Rectal suppositories with sodium hyaluronate

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

05906122471214

Basic UDI-DI

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.

5904335216czophialuEJ

Reference / catalog number

MEDCARE Rectal suppositories with sodium hyaluronate, 5 in carton, with instructions for use. Language version: English

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

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.

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

MEDCARE Sodium Hyaluronate Rectal Suppositories are a medical device with a moisturising and protective effect on the mucous membrane of the anus and rectum. It is recommended for rectal repair processes, e.g. in the case of haemorrhoids and anal fissures. It soothes and accelerates the healing of injuries resulting from surgical treatment of haemorrhoids and anal fissures. Through its protective and moisturising action, the product soothes inflammation of the anus and rectum, providing relief from persistent itching, stinging and burning of the anus and its surroundings, i.e. the perianal skin. It is also effective in preventing damage to the anus and rectum. The medical device can be used in cases of damage to the mucous membrane of the anus and rectum, commonly referred to as anal mucositis, resulting from chemotherapy, radiotherapy or a combination of both therapies. The medical device can be used in cases of irritation of the anus and rectum resulting from surgical treatment, diagnostic tests and in cases of irritation after anal penetration. The medical device alleviates discomfort associated with damage to the mucous membrane of the anus and rectum, creating conditions conducive to the natural healing and regeneration process in cases of irritation and damage to the anus and rectum. The product has a protective and moisturising effect on the mucous membrane of the anus/rectum. The product is intended for lay use.

Additional information URL

https://www.lideal.pl/

Clinical sizes

• 2 MU24

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

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

• G05TOPICAL ANORECTAL ADMINISTERED GASTRO-INTESTINAL SYSTEM DEVICES

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.