Identity
- Trade Name
- ReDS Pro EUDAMED
- Device Name
- ReDS Pro System-Refurbished EUDAMED
- Model / Reference
- V2.7(R) EUDAMEDGAS0027-R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290110070373 EUDAMED
- Basic UDI-DI
- B-07290110070373 EUDAMED
- EMDN Code
- Z12159007 BODY PLETHYSMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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-07290110070373 | 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 5114c080-c058-4266-aab8-74694dca37c7 61 fields · synced May 22, 2026