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Nihon Kohden NKV-550-N

by Nihon Kohden OrangeMed, LLC

Ref NKV-550-NModel NKV-550

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08436851NKV550K7 Basic UDI-DI 00843685100029UDI-DIDate9 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843685100029 UDI-DI Date28 Oct 2019ListedStatusListed GUDID: in commercial distribution

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.

Recalls

1 recall · FDA

    • Terminated Z-2435-2021 FDA Class II initiated 20 Jul 2021

    Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior to use.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Nihon Kohden NKV-550 Series Ventilator System EUDAMED
Nihon Kohden GUDID
Generic Name
Neonatal/adult intensive-care ventilator
Model / Ref / Catalog
NKV-550-N, NKV-550
Primary DI / UDI-DI
00843685100029
Basic UDI-DI
08436851NKV550K7
Direct Marketing DI
00843685100029
510(k) Number
FDA Product Code
CBK
EMDN Code
Z1203010504 Adult and paediatric/neonatal pulmonary ventilators
GMDN Term
Neonatal/adult intensive-care ventilator
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.5895
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K181695)

Cleared under the same submission (K192307)

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Properties

  • Administering Medicine
  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No