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Otex Olive Oil ear drops
EUDAMEDClass I (EU MDR)
Ref 100120Model Otex Olive Oil ear drops
Identity
- Trade Name
- Otex Olive Oil ear drops EUDAMED
- Device Name
- Otex Olive Oil ear drops EUDAMED
- Model / Reference
- Otex Olive Oil ear drops EUDAMED100120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016379299209 EUDAMED
- Basic UDI-DI
- B-05016379299209 EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Otex Olive Oil ear drops by Diomed Developments Limited — 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-05016379299209 | Class I | Active |
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Manufacturer
- Manufacturer
- Diomed Developments Limited
- EUDAMED SRN
- GB-MF-000004862
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED 4855b406-e903-462b-a850-a7dba5a3decc 61 fields · synced Jun 18, 2026