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Olive Oil Ear Spray
EUDAMEDClass I (EU MDR)
Ref MG-EAR-OOS01Model MG-EAR Ear Care Products
by Fbgc Limited
Identity
- Trade Name
- Olive Oil Ear Spray EUDAMED
- Device Name
- Ear Care Products EUDAMED
- Model / Reference
- MG-EAR Ear Care Products EUDAMEDMG-EAR-OOS01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060551222233 EUDAMED
- Basic UDI-DI
- 05060551221632AX EUDAMED
- Direct Marketing DI
- 05060551222233 EUDAMED
- EMDN Code
- A03040204 EAR IRRIGATION KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Olive Oil Ear Spray by Fbgc Limited — Class I — 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 | 05060551221632AX | Class I | Active |
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Manufacturer
- Manufacturer
- Fbgc Limited
- EUDAMED SRN
- UK-MF-000046785
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED f4e5fd7d-cb3f-4a97-bfb1-3677ffead083 61 fields · synced Jun 17, 2026