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Ceftriaxone
EUDAMEDClass B (EU MDR)
Ref 0043B05Ref E191831 (K)Ref E113056 (K)Ref 0043B10Ref E191831 (B)Ref 0043B30
Identity
- Trade Name
- CEFTRIAXONE EUDAMED
- Device Name
- MIC test CEFTRIAXONE EUDAMEDCEFTRIAXONE 30 (B) E113056 EUDAMED
- Model / Reference
- 0043B05 EUDAMEDE191831 (K) EUDAMEDE113056 (K) EUDAMED0043B10 EUDAMEDE191831 (B) EUDAMED0043B30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643970434 EUDAMED05902643979581 EUDAMED05902643978416 EUDAMED05902643972933 EUDAMED05902643901582 EUDAMED05902643975439 EUDAMED
- Basic UDI-DI
- 59026439BBMCROJD EUDAMED59026439BASTCROR7 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
Ceftriaxone by BioMaxima Spółka Akcyjna — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Antibacterial minimum inhibitory concentration (MIC) IVD.
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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 | 59026439BBMCROJD | Class B | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (6)
- EUDAMED af6133fb-df8a-4af9-a150-bc3a009220ba 61 fields · synced Jul 31, 2026
- EUDAMED b75d647d-916a-4a28-8650-7cf93d3fa1f8 61 fields · synced May 16, 2026
- EUDAMED e3ff02d2-f903-4362-9a9b-fbe9b6f22a62 61 fields · synced May 17, 2026
- EUDAMED 6379e5fa-236e-4748-a0ae-8298aa6b6a6a 61 fields · synced May 18, 2026
- EUDAMED 59dc1d86-684c-4b45-8540-68d62416c1f1 61 fields · synced May 18, 2026
- EUDAMED 493ba0e1-d5be-42b2-8044-10319c4e8574 61 fields · synced May 18, 2026