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StoolFix
EUDAMEDClass A (EU MDR)
Ref STF/K/15Model StoolFixRef STF/K/15/50Ref STF/K/15/3
Identity
- Trade Name
- StoolFix EUDAMED
- Device Name
- STOOLFIX MICROBIOME DNA COLLECTOR, Non-sterile EUDAMED
- Model / Reference
- StoolFix EUDAMEDSTF/K/15 EUDAMEDSTF/K/15/50 EUDAMEDSTF/K/15/3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060544100869 EUDAMED05060544100876 EUDAMED05060544100807 EUDAMED
- Basic UDI-DI
- 506054410StoolFiXDR EUDAMED
- Direct Marketing DI
- 05060544100869 EUDAMED05060544100876 EUDAMED05060544100807 EUDAMED
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
StoolFix by Cell Projects 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 | 506054410StoolFiXDR | Class A | Active |
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Manufacturer
- Manufacturer
- Cell Projects Ltd
- EUDAMED SRN
- GB-MF-000002266
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED d4597b7c-19fd-409e-abca-fd674486fd01 61 fields · synced Aug 4, 2026
- EUDAMED 0b94e2c6-b374-4c9b-9018-2bc9703ae7e4 61 fields · synced May 18, 2026
- EUDAMED 814b85cb-69f4-403e-9276-0d96282991bc 61 fields · synced May 19, 2026