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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

SECOL 10 ML — Class IIb MDR by GRUPPO FARMAIMPRESA SRL

MD Atlas
GRUPPO FARMAIMPRESA SRL

EUDAMED last updated this device on Aug 4, 2023

SECOL 10 ML

805574884FTCE16-267U

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GRUPPO FARMAIMPRESA SRL
UDI-DI code: 08055748843305
Reference / catalog number: FT.MDR.16

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View device family (Basic UDI)

Manufacturer information

Organization name: GRUPPO FARMAIMPRESA SRL
SRN: IT-MF-000012625
Manufacturer status: Active

Certificates

Certificate health across this manufacturer's portfolio.

021-00-05-MDRSupplemented
Technical documentationNotified body: 0426Expiry: Jun 21, 2028
009-00-19-MDRSupplemented
Quality management systemNotified body: 0426Expiry: Jan 9, 2028
020-00-04-MDRWithdrawn
Quality management systemNotified body: 0426Expiry: Jun 21, 2028
010-00-06-MDRWithdrawn
Quality management systemNotified body: 0426Expiry: Jan 9, 2028

Critical warnings

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

CW999
The device is not subject to special precautions of use, we note, however: - Do not use the product more than 30 days - The product may appear with two separate phases. After stirring the same should appear as a homogeneous emulsion. - Keep out of reach of children. - Do not exceed recommended dose. - Do not use after the expiration date, the expiry date refers to the product intact and properly stored. - Do not use if package is not intact. - All the components that make up the product including the dropper must be intact. - After a short period of treatment (7 days) with no significant results, consult a doctor - In case of adverse reactions suspend the use of the product and consult your doctor to fix a proper therapy. - During use, if you find the dropper dirty, clean it properly before inserting it into the bottle to prevent possible contamination. - Do not use in cases of suspected intestinal or ileus perforation. - In case of a serious accident occurring in relation to the medical device report the incident to the Manufacturer and the Competent Authority. Compliance with the instructions contained in the leaflet reduces the risk of side effects. It is important to inform your doctor or pharmacist about any side effects not listed in this insert leaflet.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: SECOL 10 ML
UDI-DI code: 08055748843305
Basic UDI-DI: 805574884FTCE16-267U
Reference / catalog number: FT.MDR.16
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Secol gtt is a medical device indicated in the treatment and in the prevention in case of: dyspeptic disorders, gastroenteric meteorism, aerophagia and gas colic in infants, children and adults.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08055748843305

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

G99GASTROINTESTINAL DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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