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Fastidious-microorganism antimicrobial susceptibility culture medium (blood)
EUDAMEDClass A (EU MDR)
Ref W11171
by Fannin Ltd.
Identity
- Device Name
- Fastidious-microorganism antimicrobial susceptibility culture medium (blood) EUDAMED
- Model / Reference
- W11171 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391511838523 EUDAMED
- Basic UDI-DI
- 5391511858603BU2 EUDAMED
- EMDN Code
- W0104010403 SUSCEPTIBILITY TEST MEDIA (PLATES) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Fastidious-microorganism antimicrobial susceptibility culture medium (blood) by Fannin Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 5391511858603BU2 | Class A | Active |
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Manufacturer
- Manufacturer
- Fannin Ltd.
- EUDAMED SRN
- IE-MF-000002373
Sources (1)
- EUDAMED beaadf8c-b4cd-43e0-8ac3-c4787ae93f6b 61 fields · synced Aug 1, 2026