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VersiHD

by NxStage Medical, Inc.

Ref NX1000-10-B

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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/MDD EUDAMED NumberB-M535NX100010B0 Basic UDI-DI M535NX100010B0UDI-DIDate5 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberM535NX100010B0 UDI-DI Date8 Dec 2021ListedStatusListed GUDID: not 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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Haemodialysis system, institutional/home-use
Model / Reference
NX1000-10-B
Primary DI / UDI-DI
M535NX100010B0
Basic UDI-DI
B-M535NX100010B0
FDA Product Code
KDI
EMDN Code
F9099 Dialysis devices - other
GMDN Term
Haemodialysis system, institutional/home-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5860
EU market of registration
Northern Ireland
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000026832
Authorised representative
Fresenius Medical Care Deutschland GmbH DE-AR-000009269

Other devices from NxStage Medical, Inc.

See all devices from NxStage Medical, Inc. →

Properties

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

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: 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