BUTYNORM Rectal suppositories, 5 suppositories in carton with instructions for use. Language version: Ukrainian

Organization name

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

SRN

PL-MF-000005402

Manufacturer status

Active

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

• CW999

  The main contraindications: 1.Hypersensitivity to any substance contained in suppositories. 2.Neoplastic changes of the rectum. 3.Severe, sharp pain in the anal area. 4.Bleeding from the rectum, spontaneous or during a bowel movement, understood as bright red blood on the stools. Contraindication 1 was formulated on the basis of a risk analysis at the design stage. Contraindication 2, 3, 4 was formulated on the basis of the knowledge that the clinical conditions listed in these sections require consultation with a physician. In these cases, the medical device rectal suppositories may be used only on an express medical prescription. The product has no influence on the ability to drive and operate machines. Do not use if package is damaged. Do not use the product after the expiry date marked on the packaging. Do not use the product if the packaging is damaged or not tampered with before opening it for the first time. The product is intended for adults. Use the product during pregnancy and breastfeeding only on explicit medical prescription. Do not use while using other rectal products and medications without consulting your doctor. Do not use vaginally. Intended only for rectal use - do not consume.

Primary placement in Poland; available across 1 country total.

Trade name

not provided

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.

05906122471191

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.

B-05906122471191

Reference / catalog number

BUTYNORM Rectal suppositories, 5 suppositories in carton with instructions for use. Language version: Ukrainian

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 IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Medical device intended for rectal use. A suppository inserted into the anal canal, after contact with the mucus produced physiologically by the goblet cells of the rectal mucosa, creates a protective coating on the mucosa surface with mucoadhesive properties. This protects and improves the hydration of the rectal mucosa. Intended for rectal use in order to: restore the natural physiological state of the rectal mucosa, support the regeneration of erosions, cracks or other defects in the rectal mucosa, alleviation of painful symptoms of emptying associated with damage to the epithelium or the presence of an inflammatory process in the rectum, supporting the regeneration of anal canal tissues after surgery or radiotherapy.

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 IIa medical devices in EUDAMED

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