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eVolution 3e Ventilator
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref EVL100500Model eVolution 3e
Identity
- Trade Name
- eVolution Ventilator EUDAMEDeVolution 3e Ventilator FDA UDI
- Generic Name
- General-purpose intensive-care ventilator FDA UDI
- Device Name
- eVolution Ventilator EUDAMEDeVolution 3e Ventilator System FDA UDI
- Model / Reference
- eVolution 3e EUDAMEDEVL100500 EUDAMEDeVolution 3e Ventilator- Turbine Essential FDA UDI
- Description
- eVolution 3e Ventilator System FDA UDI
Identifiers
- Catalog Number
- EVL100500-T, EVL100500-T-NF FDA UDI
- Primary DI / UDI-DI
- 00860008873606 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00860008873606 EUDAMED
- 510(k) Number
- K113743 FDA UDI
- FDA Product Code
- CBK FDA UDI
- EMDN Code
- R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED
- GMDN Term
- General-purpose intensive-care ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose intensive-care ventilator
eVolution 3e Ventilator by eVent Medical, Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose intensive-care ventilator.
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- EVOLUTION — eVent Medical, Ltd. · Class II
- Inspiration 7i Ventilator System — eVent Medical, Ltd. · Class II
- Inspiration 7i Ventilator System — eVent Medical, Ltd. · Class II
Cleared under the same submission
K113743 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- eVent Medical, Ltd.
Sources (2)
- FDA UDI ae012c69-20ca-4502-8a52-67b0bdb68444 36 fields · synced Jul 17, 2026
- EUDAMED a9be836c-22ea-4697-b492-37ba20acba39 61 fields · synced Jul 17, 2026