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Ciprofloxacin
EUDAMEDClass B (EU MDR)
Ref 0047B10Ref E191822 (K)Ref E113142 (B)Ref E113142 (K)Ref E191820 (K)Ref 0047B30Ref 0047B05Ref E191820 (W)
Identity
- Trade Name
- CIPROFLOXACIN EUDAMED
- Device Name
- MIC test CIPROFLOXACIN EUDAMEDCIPROFLOXACIN EUDAMED
- Model / Reference
- 0047B10 EUDAMEDE191822 (K) EUDAMEDE113142 (B) EUDAMEDE113142 (K) EUDAMEDE191820 (K) EUDAMED0047B30 EUDAMED0047B05 EUDAMEDE191820 (W) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643972971 EUDAMED05902643979604 EUDAMED05902643900509 EUDAMED05902643978508 EUDAMED05902643979598 EUDAMED05902643975477 EUDAMED05902643970472 EUDAMED05902643982598 EUDAMED
- Basic UDI-DI
- 59026439BBMCIPHL EUDAMED59026439BASTCIPQE 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
Ciprofloxacin 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 | 59026439BBMCIPHL | Class B | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (8)
- EUDAMED 14e87c33-0c26-483b-a043-d014c8c59549 61 fields · synced Aug 2, 2026
- EUDAMED b0f8a9db-22e6-4d36-94bf-57347d385ff4 61 fields · synced May 16, 2026
- EUDAMED 3eaf15ab-0a57-44dc-8813-b7582d048681 61 fields · synced May 17, 2026
- EUDAMED 23f191c3-8b00-4422-9bd0-c3a53a485e12 61 fields · synced May 18, 2026
- EUDAMED b199fd4b-5b14-44cd-9289-aa5b282541ae 61 fields · synced May 18, 2026
- EUDAMED 9cadf36a-cf3a-4265-9762-56cff81ac5de 61 fields · synced May 18, 2026
- EUDAMED 51b11413-2668-4e75-a94c-74fe44680359 61 fields · synced May 18, 2026
- EUDAMED b2ed209d-0c84-45d4-bb1c-c103fa70ad08 61 fields · synced May 19, 2026