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Nizatin®
EUDAMEDClass III (EU MDR)
Ref DXP001
by Labialfarma – Laboratório De Produtos Farmacêuticos E Nutracêuticos, S.a.
Identity
- Trade Name
- Nizatin® EUDAMED
- Device Name
- Nasal Spray Solution with 5% Dexpanthenol EUDAMED
- Model / Reference
- DXP001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05600767644193 EUDAMED
- Basic UDI-DI
- B-05600767644193 EUDAMED
- EMDN Code
- Q030103 NASAL IRRIGATION SOLUTIONS 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
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Nizatin® 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-05600767644193 | Class III | Active |
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Manufacturer
- EUDAMED SRN
- PT-MF-000003551
Sources (1)
- EUDAMED bd76f2e0-01c7-4775-b397-762a95fbdfaa 61 fields · synced Jul 17, 2026