Identity
- Trade Name
- Simex 80 mg 20 tablettia EUDAMED
- Device Name
- Simex 80 mg EUDAMED
- Model / Reference
- 1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430037940507 EUDAMED
- Basic UDI-DI
- B-06430037940507 EUDAMED
- EMDN Code
- G0401 ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Simex 80 mg 20 tablettia by Galena Pharma Oy — Class IIa — 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-06430037940507 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Galena Pharma Oy
- EUDAMED SRN
- FI-MF-000000588
Sources (1)
- EUDAMED 9ab412fd-ff96-4c5f-aca1-67412ab56164 61 fields · synced Jul 15, 2026