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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

SCS000 — Class III MDD by LABIALFARMA –…

MD Atlas
LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.

EUDAMED last updated this device on Sep 6, 2023

SCS000

B-PTMF000003551SCS0009G

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.
UDI-DI code: D-PTMF000003551SCS0009G
Reference / catalog number: SCS000

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View device family (Basic UDI)

Manufacturer information

Organization name: LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.
SRN: PT-MF-000003551
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW999
Warnings: Keep out of the sight and reach of children. Please carefully read the accompanying instructions of use leaflet before using this product. Only take this product as intended, in the event of misuse, seek medical advice. Do not take in case of hypersensitivity or allergy to any of the components. In case of pregnancy and/or breast-feeding, you should consult your doctor or pharmacist before using this medical device. Do not exceed the recommended dose. Recommended usage time is 10 days. If symptoms persist after this period, consult your doctor or pharmacist. Do not take this product after the expiry date which is stated on the blister and carton box. Do not use the product if the box is open or damage.
CW999
Contra-Indications: - In children under 15 years old. - In case of hypersensitivity to any of the ingredients. - If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medical device.

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Market distribution

Primary placement in Portugal; available across 1 country total.

Country	On market since	Until
PortugalPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-PTMF000003551SCS0009G
Basic UDI-DI: B-PTMF000003551SCS0009G
Reference / catalog number: SCS000
Issuing entity: EUDAMED

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Medical device for oral use, not subject to medical prescription. The formulation contains simethicone which acts in a way to reduce the tension surface of the gas bubbles of the intestinal tract, and consequently eliminate them. The medical device is presented in carton box with 30 soft capsules.
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

D-PTMF000003551SCS0009G

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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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