Identity
- Trade Name
- Pediatuss 10 mL IT EUDAMED
- Device Name
- Children Cough syrup EUDAMED
- Model / Reference
- FTPR38 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056300621041 EUDAMED
- Basic UDI-DI
- 805630062FTPR389R EUDAMED
- EMDN Code
- V9017 ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa 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
Pediatuss 10 mL IT by Labomar S.p.A. — Class IIa — 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 | 805630062FTPR389R | Class IIa | Active |
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Manufacturer
- Manufacturer
- Labomar S.p.A.
- EUDAMED SRN
- IT-MF-000007965
Sources (1)
- EUDAMED 424e519f-4788-4df7-a7fb-7701ebe21b74 61 fields · synced Jul 18, 2026