Identity
- Trade Name
- KAROS GOLA PASTIGLIE EUDAMED
- Device Name
- Orodispersible Tablets HA + Carbomer + Xanthan Gum EUDAMED
- Model / Reference
- 72TA01 EUDAMED8033638951187 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033638951187 EUDAMED
- Basic UDI-DI
- 803363895CO0015R EUDAMED
- Direct Marketing DI
- 08033638951187 EUDAMED
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Karos Gola Pastiglie by IBSA Farmaceutici Italia Srl — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803363895CO0015R | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ibsa Farmaceutici Italia Srl
- EUDAMED SRN
- IT-MF-000008111
Sources (1)
- EUDAMED fe3c7570-ef98-4dcf-af4e-30dc5a463233 61 fields · synced Aug 3, 2026