Identity
- Trade Name
- CLINDAMYCIN EUDAMED
- Device Name
- MIC test CLINDAMYCIN EUDAMED
- Model / Reference
- 0050B10 EUDAMED0050B05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643973008 EUDAMED05902643970502 EUDAMED
- Basic UDI-DI
- 59026439BBMDAJD 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
Clindamycin by BioMaxima Spółka Akcyjna — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Antibacterial minimum inhibitory concentration (MIC) IVD.
- ETEST® Benzylpenicillin (PG) — BIOMERIEUX , INC. · Class II
- ETEST® Minocycline (MC) — BIOMERIEUX , INC. · Class II
- Etest® TIGECYCLINE — BIOMERIEUX , INC. · Class II
- ETEST® Ertapenem (ETP) — BIOMERIEUX , INC. · Class II
- ETEST® Fosfomycin (FO) — BIOMERIEUX , INC. · Class II
- ETEST® Ertapenem (ETP) — BIOMERIEUX , INC. · Class II
- ETEST® ESBL Cefotaxime/cefotaxime + clavulanic acid (CT/CTL) — BIOMERIEUX , INC. · Class II
- ETEST® Ciprofloxacin (CI) — BIOMERIEUX , INC. · Class II
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 | 59026439BBMDAJD | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (2)
- EUDAMED a01bd557-b06f-47d5-b1e2-a77ff40d1d18 61 fields · synced Jul 12, 2026
- EUDAMED 803e8415-a8d6-407d-b22b-a6d0465f8733 61 fields · synced May 17, 2026