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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

FT.MDR.26 — Class IIb MDR by GRUPPO FARMAIMPRESA SRL

MD Atlas
GRUPPO FARMAIMPRESA SRL

EUDAMED last updated this device on Dec 5, 2023

FT.MDR.26

805574884FTCE16-267U

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GRUPPO FARMAIMPRESA SRL
UDI-DI code: 04008491110303
Reference / catalog number: FT.MDR.26

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View device family (Basic UDI)

Manufacturer information

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

Related devices

FT.MDR.16.8.10805574884FTCE16-267UOn the market ACID-EAZE PLUSB-FT.CE.107.FA.5.12RROn the market FT\MDR\26.14.100805574884FTCE16-267UOn the market FT\MDR\26.14805574884FTCE16-267UOn the market ALGIBABY SODB-FT.CE.107.FH.1.12TQOn the market

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
Lesen Sie die Packungsbeilage aufmerksam durch. Außerhalb der Reichweite von Kindern aufbewahren. Bei einer Temperatur von 5 °C – 25 °C lagern. Bewahren Sie das Produkt korrekt verschlossen und fernab von Hitzequellen auf. Das Produkt sollte innerhalb von 30 Tagen nach dem Öffnen verbraucht werden.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04008491110303
Basic UDI-DI: 805574884FTCE16-267U
Reference / catalog number: FT.MDR.26
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: Tetesept Baby Bäuchlein Entspannungs Tropfen ist ein Medizinprodukt, das zur Behandlung der folgenden Erkrankungen bei Babys, Kindern und Erwachsenen verwendet werden kann: Verdauungsbeschwerden, übermäßige Gasansammlung im Gastrointestinaltrakt mit Luftaufstoßen, Blähbauch, Schmerzen und Flatulenz, Aerophagie (Luftschlucken) oder Gaskoliken.
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)04008491110303

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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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