Identity
- Trade Name
- RejuvenAir EUDAMED
- Device Name
- RejuvenAir System - Console EUDAMEDRejuvenAir System - Catheter Kit EUDAMED
- Model / Reference
- 20-00190 EUDAMED20-00189 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00857068006167 EUDAMED10857068006126 EUDAMED
- Basic UDI-DI
- B-00857068006167 EUDAMEDB-10857068006126 EUDAMED
- EMDN Code
- R0799 BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
RejuvenAir by CSA Medical — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00857068006167 | Class IIb | No Longer Active |
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Manufacturer
- Manufacturer
- CSA Medical
- EUDAMED SRN
- US-MF-000026367
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED 591ef585-2e2b-4251-b61c-feef8d548430 61 fields · synced Jul 28, 2026
- EUDAMED fdbce22c-0878-440d-944a-8d27b4a93f17 61 fields · synced May 18, 2026