Identity
- Trade Name
- Procise Stool Collection Kit EUDAMED
- Device Name
- Procise Stool Collection Kit EUDAMED
- Model / Reference
- 4913 EUDAMED4912 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08100322949123 EUDAMED
- Basic UDI-DI
- 081003229PDXE491222VJ EUDAMED
- Direct Marketing DI
- 08100322949123 EUDAMED
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Procise Stool Collection Kit by ProciseDx Inc. — 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 | 081003229PDXE491222VJ | Class A | Active |
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Manufacturer
- Manufacturer
- ProciseDx Inc.
- EUDAMED SRN
- US-MF-000040747
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 48b8800d-5f22-4bbe-88db-2f5563aed1ea 61 fields · synced Jul 9, 2026