Identity
- Device Name
- Feces Analysis System EUDAMED
- Model / Reference
- 5A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971124110040 EUDAMED
- Basic UDI-DI
- 697112411FAS00137 EUDAMED
- Direct Marketing DI
- 06971124110040 EUDAMED
- EMDN Code
- W0101060399 FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
New Device
No
EUDAMED
Feces Analysis System by Xiamen Sciendox Biological Technology Co., 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 | 697112411FAS00137 | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Sciendox Biological Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000029485
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED e0518207-7912-4361-a05c-f94fce0d3e1c 61 fields · synced Jun 18, 2026