Identity
- Trade Name
- ReDS Pro EUDAMED
- Device Name
- ReDS Pro System EUDAMED
- Model / Reference
- V2.7 EUDAMEDGAS0027 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290110070298 EUDAMED
- Basic UDI-DI
- B-07290110070298 EUDAMED
- EMDN Code
- Z12159007 BODY PLETHYSMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ReDS Pro by Sensible Medical Innovations Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290110070298 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sensible Medical Innovations Ltd.
- EUDAMED SRN
- IL-MF-000029801
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 1832e8ad-dc0d-4c68-a12e-991b36834631 61 fields · synced May 23, 2026