Identity
- Trade Name
- ProtectOhr EUDAMED
- Device Name
- ProtectOhr Ohren Reinigungsspray 20ml EUDAMED
- Model / Reference
- 387 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-3877R EUDAMED
- Basic UDI-DI
- B-3877R EUDAMED
- EMDN Code
- Q03040299 EAR IRRIGATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
ProtectOhr 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-3877R | Class I | Active |
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Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (1)
- EUDAMED e3a12260-8515-4f65-a49b-5009fc041dec 61 fields · synced Jul 19, 2026