Identity
- Trade Name
- Emergency and Transport Ventilator EUDAMED
- Device Name
- Emergency and Transport Ventilator EUDAMED
- Model / Reference
- V1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429021400 EUDAMED
- Basic UDI-DI
- 69454290EV001MG EUDAMED
- Direct Marketing DI
- 06945429021400 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 — CE/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 (1)
- EUDAMED a54a32a8-944c-4094-93dd-9a3a9a910f33 61 fields · synced Oct 6, 2026