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Flatoff®
EUDAMEDClass III (EU MDR)
Ref SCS000
by Labialfarma – Laboratório De Produtos Farmacêuticos E Nutracêuticos, S.a.
Identity
- Trade Name
- FLATOFF® EUDAMED
- Device Name
- Soft Capsules Simethicone EUDAMED
- Model / Reference
- SCS000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-PTMF000003551SCS0009G EUDAMED
- Basic UDI-DI
- B-PTMF000003551SCS0009G EUDAMED
- EMDN Code
- G99 GASTROINTESTINAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Flatoff® by Labialfarma – Laboratório De Produtos Farmacêuticos E Nutracêuticos, S.a. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-PTMF000003551SCS0009G | Class III | Active |
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Manufacturer
- EUDAMED SRN
- PT-MF-000003551
Sources (1)
- EUDAMED 0d30792e-ae54-4610-a322-419fe512afc8 61 fields · synced Jul 9, 2026