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Revaxör örondroppar
EUDAMEDClass IIa (EU MDR)
Ref 100271Ref 163645
by Orion Oyj
Identity
- Trade Name
- Revaxör örondroppar EUDAMED
- Device Name
- Remo-Wax EUDAMED
- Model / Reference
- 100271 EUDAMED163645 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06432100014634 EUDAMED06432100106261 EUDAMED
- Basic UDI-DI
- 643210REM001UD EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Revaxör örondroppar 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 9eaeb26d-36b7-45f8-a413-2642cd2f420b 61 fields · synced Jul 16, 2026
- EUDAMED 104c6402-80d2-42ef-a883-9d4d83b9127b 61 fields · synced Jul 16, 2026