Identity
- Trade Name
- Doppelherz aktiv Iritakolin BG EUDAMED
- Device Name
- NORMOBOWELL COMPRESSE I.B.S. EUDAMED
- Model / Reference
- FTP054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FTP054_8KB EUDAMED
- Basic UDI-DI
- B-FTP054_8KB EUDAMED
- EMDN Code
- G0401 ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium 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
Doppelherz aktiv Iritakolin BG by Labomar S.p.A. — Class IIb — 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-FTP054_8KB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Labomar S.p.A.
- EUDAMED SRN
- IT-MF-000007965
Sources (1)
- EUDAMED 7a658ca1-569d-42ca-9858-451a82df7acc 61 fields · synced Jun 18, 2026