Identity
- Trade Name
- Lucovit EUDAMEDLucovit Cough&Throat Spr CE EUDAMED
- Device Name
- Lucovit Otixyl Ear Spray 20ml EUDAMEDCough&Throat Spr CE EUDAMED
- Model / Reference
- 018713 EUDAMED070520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-018713N6 EUDAMEDD-070520N3 EUDAMED
- Basic UDI-DI
- B-018713N6 EUDAMEDB-070520N3 EUDAMED
- EMDN Code
- Q03040299 EAR IRRIGATION DEVICES - OTHER EUDAMEDR028099 RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Malta EUDAMEDNetherlands 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
Lucovit by PK Benelux BV — Class I — 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-018713N6 | Class I | Active |
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Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (2)
- EUDAMED 9fd94fdd-8a62-4ee3-b04b-5419926070c3 61 fields · synced Jul 9, 2026
- EUDAMED b6d6442f-a5f2-46a2-9498-a57cc0438f7e 61 fields · synced May 18, 2026