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Neonatal and Pediatric Ventilators

EUDAMED

Class IIb (EU MDR)

Ref VN6SModel VN8S HFORef VN6Ref NV10BModel NV10

by Shenzhen Comen Medical Instruments Co., LTD.

Identity

Trade Name
Neonatal and Pediatric Ventilators EUDAMED
Device Name
Neonatal and Pediatric Ventilators EUDAMED
Model / Reference
VN8S HFO EUDAMED
VN6S EUDAMED
VN6 EUDAMED
NV10 EUDAMED
NV10B EUDAMED

Identifiers

Primary DI / UDI-DI
06945429060898 EUDAMED
06945429060904 EUDAMED
06945429024869 EUDAMED
Basic UDI-DI
69454290VN001RK EUDAMED
69454290NV002QM EUDAMED
Direct Marketing DI
06945429060898 EUDAMED
06945429060904 EUDAMED
06945429024869 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

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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 b84a6a75-75cf-40e0-afc6-0ee28eba6198 61 fields · synced Oct 6, 2026
  • EUDAMED 6afb6df9-1ed8-41e3-a3e9-c09eaf557501 61 fields · synced May 18, 2026
  • EUDAMED 99e98ad3-856c-4fae-b1e0-2f950a3c8cfc 61 fields · synced May 19, 2026