← Back to catalogue
Cefepime
EUDAMEDClass B (EU MDR)
Ref 0018B05Ref 0017B05Ref 0018B30Ref 0017B10Ref E113002 (B)Ref E113002 (K)Ref 0017B30
Identity
- Trade Name
- CEFEPIME EUDAMED
- Device Name
- MIC test CEFEPIME EUDAMEDCEFEPIME 30 (B) E113002 EUDAMED
- Model / Reference
- 0018B05 EUDAMED0017B05 EUDAMED0018B30 EUDAMED0017B10 EUDAMEDE113002 (B) EUDAMEDE113002 (K) EUDAMED0017B30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643970182 EUDAMED05902643970175 EUDAMED05902643975187 EUDAMED05902643972674 EUDAMED05902643900202 EUDAMED05902643978201 EUDAMED05902643975170 EUDAMED
- Basic UDI-DI
- 59026439BBMFEPHP EUDAMED59026439BASTFEPQH EUDAMED
- EMDN Code
- W0104080501 MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST) EUDAMEDW0104080502 IMPREGNATED DISKS, MULTI-DISKS & TABLETS 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
Cefepime 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 | 59026439BBMFEPHP | 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 (7)
- EUDAMED 9eaad3cd-32e3-4cc4-9e02-eda8a7503310 61 fields · synced Aug 4, 2026
- EUDAMED 93e33bed-f8c3-4670-9562-7a29ea3b7455 61 fields · synced May 17, 2026
- EUDAMED 19b14254-0480-467b-a97b-09be41439492 61 fields · synced May 17, 2026
- EUDAMED ccc71fc5-d334-401a-972c-a39f9a45650e 61 fields · synced May 18, 2026
- EUDAMED 3d2f36bc-0aff-4250-b565-2fcc9063bb6a 61 fields · synced May 18, 2026
- EUDAMED e06c3c78-a910-4e96-9cb8-5451d587b3eb 61 fields · synced May 18, 2026
- EUDAMED 7d45c7b8-4d9a-459f-89a9-690242175699 61 fields · synced May 19, 2026