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Sodium Bicarbonate Ear Drops
EUDAMEDClass I (EU MDR)
Ref MG-EAR-SED01Model MG-EAR Ear Care Products
by Fbgc Limited
Identity
- Trade Name
- Sodium Bicarbonate Ear Drops EUDAMED
- Device Name
- Ear Care Products EUDAMED
- Model / Reference
- MG-EAR Ear Care Products EUDAMEDMG-EAR-SED01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060551221960 EUDAMED
- Basic UDI-DI
- 05060551221632AX EUDAMED
- Direct Marketing DI
- 05060551221960 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
Sodium Bicarbonate Ear Drops 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 8e1e6665-d685-48b1-87c5-f05c8058d9ce 61 fields · synced Jul 20, 2026