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Emergency and Transport Ventilator
EUDAMEDClass IIb (EU MDR)
Ref V1AModel V1 Ref V1CRef V1 Pro
Identity
- Trade Name
- Emergency and Transport Ventilator EUDAMED
- Device Name
- Emergency and Transport Ventilator EUDAMED
- Model / Reference
- V1 EUDAMEDV1A EUDAMEDV1C EUDAMEDV1 Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429021417 EUDAMED06945429024814 EUDAMED06945429061352 EUDAMED
- Basic UDI-DI
- 69454290EV001MG EUDAMED
- Direct Marketing DI
- 06945429021417 EUDAMED06945429024814 EUDAMED06945429061352 EUDAMED
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL 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 | 69454290EV001MG | 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 (3)
- EUDAMED 4cb513cb-47f7-4959-b0f9-bd57e9571e8a 61 fields · synced Oct 6, 2026
- EUDAMED 595808c8-75f3-4891-8849-562093367923 61 fields · synced May 17, 2026
- EUDAMED 5ce16d70-0d65-4d72-aa2d-1bea5b6be415 61 fields · synced May 18, 2026