Identity
- Trade Name
- Revitive Aerosure EUDAMED
- Device Name
- Revitive Aerosure EUDAMED
- Model / Reference
- 3481AJ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50602174934812 EUDAMED
- Basic UDI-DI
- 5060217493481AJDD EUDAMED
- EMDN Code
- R050280 RESPIRATORY TRACT EXPANSION SYSTEMS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Revitive Aerosure by Actegy Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5060217493481AJDD | Class I | Active |
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Manufacturer
- Manufacturer
- Actegy Limited
- EUDAMED SRN
- GB-MF-000032543
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 3f4a8606-ebed-4c97-840e-8b624204de52 61 fields · synced Jul 10, 2026