Identity
- Trade Name
- AMOXICILLIN EUDAMEDAMOXICILLIN - CLAVULANIC ACID EUDAMED
- Device Name
- MIC test AMOXICILLIN EUDAMEDMIC test AMOXICILLIN - CLAVULANIC EUDAMED
- Model / Reference
- 0002B10 EUDAMED0004B05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643972520 EUDAMED05902643970045 EUDAMED
- Basic UDI-DI
- 59026439BBMAXKJ EUDAMED59026439BBMAMCGU EUDAMED
- EMDN Code
- W0104080501 MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Antibacterial minimum inhibitory concentration (MIC) IVD
Amoxicillin by BioMaxima Spółka Akcyjna — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 59026439BBMAXKJ | Class B | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (2)
- EUDAMED 7ad9621e-5641-43a5-badf-d0b0042006b2 61 fields · synced Jul 22, 2026
- EUDAMED 0f60d6e0-5c71-48cd-8207-fd67ab782db5 61 fields · synced May 18, 2026