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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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Soft Capsules Simethicone — 1 UDI-DI variant, MDD

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

Data from EUDAMED, last updated May 30, 2026

Soft Capsules Simethicone

B-PTMF000003551SCS0009G

1 UDI-DI variant

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

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Manufacturer: LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.

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Device characteristics

Incorporates a medicinal productAnimal tissues / cells

Legacy certificates

Certificate number: 2021 05 0957 CT
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS (0318)
Validity: May 26, 2024

Certificate number: 2021 05 0958 ED
Type: refdata.legacy.mdd-certificate-type.ii-4
Notified body: CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS (0318)
Validity: May 26, 2024

Identity & classification

Basic UDI-DI: B-PTMF000003551SCS0009G
Device name: Soft Capsules Simethicone
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Version date: Sep 6, 2023

Manufacturer & authorised representative

Manufacturer

Name: LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.
SRN: PT-MF-000003551
Country: Portugal
Email: mdvigilance@labialfarma.com
Phone: +351 231 927 590

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01H9JF65KXMMD21XV9SY5PDR3E

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

SCS000D-PTMF000003551SCS0009G