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Paradevice Stool Sampling and Fixing device
EUDAMEDClass A (EU MDR)
Ref 117-007
Identity
- Device Name
- Paradevice Stool Sampling and Fixing device EUDAMED
- Model / Reference
- 117-007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850085309068 EUDAMED
- Basic UDI-DI
- 00850085309001007TP EUDAMED
- EMDN Code
- W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES 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
Paradevice Stool Sampling and Fixing device by Reingenuity 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 | 00850085309001007TP | Class A | Active |
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Manufacturer
- Manufacturer
- Reingenuity Ltd
- EUDAMED SRN
- UK-MF-000052788
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED 0fffc719-2bf8-4e51-b501-defaf064c2c8 61 fields · synced Jun 19, 2026