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Neonatal and Pediatric Ventilators
EUDAMEDClass IIb (EU MDR)
Ref NV10AModel NV10
Identity
- Trade Name
- Neonatal and Pediatric Ventilators EUDAMED
- Device Name
- Neonatal and Pediatric Ventilators EUDAMED
- Model / Reference
- NV10 EUDAMEDNV10A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429024852 EUDAMED
- Basic UDI-DI
- 69454290NV002QM EUDAMED
- Direct Marketing DI
- 06945429024852 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 | 69454290NV002QM | 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 469758e8-a11c-4788-a825-500489439d94 61 fields · synced Jun 18, 2026