Identity
- Trade Name
- Audisol EUDAMED
- Device Name
- Audisol Ear Wax Remover 20ml EUDAMED
- Model / Reference
- 073033DKSH EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-073033DKSHCJ EUDAMED
- Basic UDI-DI
- B-073033DKSHCJ EUDAMED
- EMDN Code
- Q03040299 EAR IRRIGATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Audisol 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-073033DKSHCJ | Class I | Active |
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Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (1)
- EUDAMED eca1d8f0-4097-4c01-bca3-da8f2db2f271 61 fields · synced Jul 12, 2026