Identity
- Trade Name
- Remo-wax øredråber EUDAMEDRemo-wax øredråber med sprøjte EUDAMED
- Device Name
- Remo-Wax EUDAMED
- Model / Reference
- 100428 EUDAMED100427 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06432100001689 EUDAMED06432100001740 EUDAMED
- Basic UDI-DI
- 643210REM001UD EUDAMED643210RPP001YT EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
- Medical Purpose
- Dissolve impacted ear wax 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
Remo-wax øredråber by Orion Oyj — 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 | 643210REM001UD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Orion Oyj
- EUDAMED SRN
- FI-MF-000001595
Sources (2)
- EUDAMED 29415327-b15d-4262-a064-8d4c475313a4 61 fields · synced Jul 12, 2026
- EUDAMED d311adae-ed79-4538-b78d-e895fe8e8a8f 61 fields · synced May 19, 2026