Gelsectan Ibutin

Organization name

DEVINTEC SAGL

SRN

CH-MF-000020271

Manufacturer status

Active

3 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)
• Do not use if package is damaged
• P102 – Keep out of reach of children.

Primary placement in Italy; available across 6 countries total.

Trade name

Gelsectan Ibutin

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.

07649993626021

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.

7649993626FT42301VC

Reference / catalog number

C05B02E015

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 III

Applicable legislation

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

Status

On the market

Quantity

15

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• size "00"

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

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

• G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.