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Prismaflex M100 set

by Vantive Health GmbH

Ref 106697MDR

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 ongoing

This device is named in the recall

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 Number7332414VA0000262Z Basic UDI-DI 07332414201340UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07332414201340 UDI-DI Date27 Mar 2026ListedStatusListed 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.

Recalls

7 recalls · 2 ongoing · FDA

    • Ongoing Z-1227-2026 FDA Class II initiated 6 Jan 2026

    There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

    • Ongoing Z-0081-2023 FDA Class II initiated 14 Sep 2022

    Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.

    • Terminated Z-2378-2021 FDA Class II initiated 22 Jul 2021

    Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter. Data was manipulated to appear to be conforming

  • 2 recalls, same reason

    • Terminated Z-2201-2014 FDA Class II initiated 18 Jul 2014
    • Terminated Z-2202-2014 FDA Class II initiated 18 Jul 2014

    Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

    • Terminated Z-0695-2007 FDA Unclassified (pre-2012) initiated 4 Jan 2007

    Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)

    • Terminated Z-0032-2007 FDA Unclassified (pre-2012) initiated 16 May 2006

    A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.

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
Prismaflex M100 set EUDAMED
Prismaflex Set M100 GUDID
Generic Name
Haemofilter
Device Name
Prismaflex M set and Prismaflex ST set
Model / Ref / Catalog
106697MDR
Primary DI / UDI-DI
07332414201340
Basic UDI-DI
7332414VA0000262Z
510(k) Number
FDA Product Code
KDI
EMDN Code
F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES
GMDN Term
Haemofilter
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5860
EU market of registration
Italy
GUDID distribution status
Not in Commercial Distribution
Size
Width — 22 Centimeter
Weight — 814 Gram
Height — 9 Centimeter
Length — 27 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CH-MF-000038981
Authorised representative
Vantive S.r.l. IT-AR-000041309

Other devices from Vantive Health GmbH

See all devices from Vantive Health GmbH →

Properties

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

Other properties (18)

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