Identity
- Trade Name
- AMPICILLIN-SULBACTAM EUDAMED
- Device Name
- MIC test AMPICILLIN-SULBACTAM EUDAMED
- Model / Reference
- 0007B30 EUDAMED0007B05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643975071 EUDAMED05902643970076 EUDAMED
- Basic UDI-DI
- 59026439BBMSAMK6 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
Ampicillin-Sulbactam 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 | 59026439BBMSAMK6 | Class B | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (2)
- EUDAMED 27e753b6-f753-4a7d-8bcb-f1f17edf37a2 61 fields · synced Jul 14, 2026
- EUDAMED 2043ae2d-179f-4cb7-aa7c-52887f5070d2 61 fields · synced May 19, 2026