Identity
- Trade Name
- Stool Collection Tube EUDAMED
- Device Name
- Stool Collection Tube EUDAMED
- Model / Reference
- FPS EUDAMED250101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931302386 EUDAMED
- Basic UDI-DI
- 69559313002025010001Q2 EUDAMED
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Stool Collection Tube by Yaneng BIOscience (Shenzhen) 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 | 69559313002025010001Q2 | Class A | Active |
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Manufacturer
- Manufacturer
- Yaneng BIOscience (Shenzhen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013666
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 32620776-faca-46eb-96b9-691e563c82d3 61 fields · synced Jun 19, 2026