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Neonatal and Pediatric Ventilators
EUDAMEDClass IIb (EU MDR)
Ref VN8SModel VN8S HFO
Identity
- Trade Name
- Neonatal and Pediatric Ventilators EUDAMED
- Device Name
- Neonatal and Pediatric Ventilators EUDAMED
- Model / Reference
- VN8S HFO EUDAMEDVN8S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429060935 EUDAMED
- Basic UDI-DI
- 69454290VN001RK EUDAMED
- Direct Marketing DI
- 06945429060935 EUDAMED
- EMDN Code
- Z1203010503 NEONATAL/PAEDIATRIC 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
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Neonatal and Pediatric Ventilators 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 | 69454290VN001RK | 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 7e26fa1d-1a10-4c59-931a-fc3604b4a00b 61 fields · synced Oct 5, 2026