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Product name: Emergency and Transport Ventilator
EUDAMEDClass IIb (EU MDR)
Ref EV2AModel EV2
Identity
- Trade Name
- Product name: Emergency and Transport Ventilator EUDAMED
- Device Name
- Emergency and Transport Ventilator EUDAMED
- Model / Reference
- EV2 EUDAMEDEV2A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429025071 EUDAMED
- Basic UDI-DI
- 69454290EV003ML EUDAMED
- Direct Marketing DI
- 06945429025071 EUDAMED
- EMDN Code
- Z12030104 PORTABLE PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIb 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
Product name: Emergency and Transport Ventilator by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — MDR — listed in EUDAMED
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 | 69454290EV003ML | 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 90f8a81e-f8e0-42c9-8229-0659f6d6c266 61 fields · synced Jun 18, 2026