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Nxstage Cartridge Express

by NxStage Medical, Inc.

Ref CAR-172-C

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

CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K061837↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-M535CAR172C0 Basic UDI-DI M535CAR172C0UDI-DIDate9 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberM535CAR172C0 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK061837 Date31 Jul 2006IssuedStatusActive

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-1228-2007 FDA Unclassified (pre-2012) initiated 27 Jul 2007

    Potential for dialysate leaks from the cartridge during treatment.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Haemodialysis/haemofiltration system component set
Model / Reference
CAR-172-C
Primary DI / UDI-DI
M535CAR172C0
Basic UDI-DI
B-M535CAR172C0
FDA Product Code
KDI
EMDN Code
F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES
GMDN Term
Haemodialysis/haemofiltration system component set
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5860
EU market of registration
Northern Ireland
GUDID distribution status
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

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No