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Emergency and transport ventilator
EUDAMEDClass IIb (EU MDR)
Ref EV5AModel EV3,EV5
Identity
- Trade Name
- Emergency and transport ventilator EUDAMED
- Device Name
- Emergency and Transport Ventilator,Ventilator EUDAMED
- Model / Reference
- EV3,EV5 EUDAMEDEV5A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429025033 EUDAMED
- Basic UDI-DI
- 69454290EV002MJ EUDAMED
- Direct Marketing DI
- 06945429025033 EUDAMED
- EMDN Code
- Z12030104 PORTABLE PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Emergency and transport ventilator by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — 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 | 69454290EV002MJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED fce12775-7798-45de-84ab-5afb28377992 61 fields · synced Oct 6, 2026