Identity
- Device Name
- STOOL COLLECTION TUBE EUDAMED
- Model / Reference
- 31327 EUDAMED31329 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287108835 EUDAMED08435287111927 EUDAMED
- Basic UDI-DI
- 8435287121STLCOLTUBE47 EUDAMED
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
No
EUDAMED
Stool Collection Tube by Biosystems S.a. — 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 | 8435287121STLCOLTUBE47 | Class A | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (2)
- EUDAMED c3b58b2a-c05f-4f9a-96aa-023a5bb2469a 61 fields · synced Jul 9, 2026
- EUDAMED 3594746c-e26d-49ee-b1df-43f34d9fbd83 61 fields · synced May 18, 2026