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Xn Check Nsh-100g

by Sysmex Corporation

Ref BV166979

Xn Check Nsh-100g (BV166979) is a device classified as IVD General (EU), Class II (US) made by Sysmex Corporation, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI B-14987562502766), cleared under FDA 510(k) K160590 on 22 Dec 2016 and listed in FDA GUDID since 18 Jan 2021 (UDI-DI 14987562502766), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160590

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-14987562502766 Basic UDI-DI 14987562502766UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14987562502766 UDI-DI Date18 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160590 Date22 Dec 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-14987562502766 registered 16 Oct 2026 Active
  • FDA 510(k) K160590 decided 22 Dec 2016 Active
  • FDA GUDID UDI-DI 14987562502766 listed 18 Jan 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160590
  2. Listed FDA GUDID 14987562502766
  3. Registered EUDAMED B-14987562502766

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Xn Check
Generic name
Full blood count IVD, control
Model / Ref / Catalog
BV166979, NSH-100G
Primary DI / UDI-DI
14987562502766
Basic UDI-DI
B-14987562502766
510(k) Number
FDA product code
JPK
EMDN code
W0103010503 Multilevel blood controls
GMDN term
Full blood count IVD, control
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
864.8625
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 3.0 Milliliter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BV166979
GUDID
NSH-100G
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Full blood count IVD, control

Cleared under the same submission (K160590)

Similar devices in this category

Other devices filed under MULTILEVEL BLOOD CONTROLS.

Other devices from Sysmex Corporation

See all devices from Sysmex Corporation →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)