Identity
- Trade Name
- Lucovital Mouth Ulcer EUDAMED
- Device Name
- Mouth Ulcer EUDAMED
- Model / Reference
- 080314 EUDAMED071404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-080314N9 EUDAMEDD-071404N7 EUDAMED
- Basic UDI-DI
- B-080314N9 EUDAMEDB-071404N7 EUDAMED
- EMDN Code
- M04041503 DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Lucovital Mouth Ulcer by PK Benelux BV — 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-080314N9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (2)
- EUDAMED 0210dd67-c557-421c-8e1d-e18fb87e773b 61 fields · synced Jul 9, 2026
- EUDAMED 3d407326-eb59-4c46-af94-a2f8bd85ea5e 61 fields · synced May 17, 2026