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Fastidious-microorganism antimicrobial susceptibility culture medium (ADD)
EUDAMEDClass A (EU MDR)
Ref W11155
by Fannin Ltd.
Identity
- Device Name
- Fastidious-microorganism antimicrobial susceptibility culture medium (ADD) EUDAMED
- Model / Reference
- W11155 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391511830695 EUDAMED
- Basic UDI-DI
- 5391511858603ATY 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
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
Fastidious-microorganism antimicrobial susceptibility culture medium (ADD) 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 | 5391511858603ATY | Class A | Active |
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Manufacturer
- Manufacturer
- Fannin Ltd.
- EUDAMED SRN
- IE-MF-000002373
Sources (1)
- EUDAMED 07d8da5d-e523-4e18-9f51-2dc3ebc1de33 61 fields · synced Jun 19, 2026