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INOwill

by Nanjing Novlead Biotechnology Co., Ltd. 2 variants

Ref /

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697345471N200GH Basic UDI-DI 06973454710020UDI-DIDate10 Oct 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
INOwill Nitric Oxide Generator and Delivery System
Model / Reference
/
Primary DI / UDI-DI
06973454710020
Basic UDI-DI
697345471N200GH
Direct Marketing DI
06973454710020
EMDN Code
Z12159099 Various pneumology and respiratory physiopathology instruments - other
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000023197
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Nanjing Novlead Biotechnology Co., Ltd.

Properties

  • Administering Medicine
  • Measuring Function

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Incorporates Medicinal Product: No