Skip to content

TruWave MP111

by Edwards Lifesciences LLC

Ref MP111

TruWave MP111 is a blood pressure transducer holder (EU MDR Class I; FDA Class I; FDA product code FOX, Stand, Infusion) made by Edwards Lifesciences LLC, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI 0690103D001TRC000Y2), cleared under FDA 510(k) K925638 on 18 Oct 1993 and listed in FDA GUDID since 15 Jul 2025 (UDI-DI 07460691956148), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

1 closed

Documents

None, self-declared

Class I: no certifier involved

510(k) K925638

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001TRC000Y2 Basic UDI-DI 07460691956148UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07460691956148 UDI-DI Date15 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK925638 Date18 Oct 1993DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0690103D001TRC000Y2 registered 30 Sep 2026 Active
  • FDA 510(k) K925638 decided 18 Oct 1993 Active
  • FDA GUDID UDI-DI 07460691956148 listed 15 Jul 2025 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

1 recall · FDA

    • Terminated Z-1146-2013 FDA Class II initiated 30 Jan 2013 on shared 510(k) K925638

    The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K925638
  2. Recall initiated FDA recalls Z-1146-2013
  3. Listed FDA GUDID 07460691956148
  4. Registered EUDAMED 0690103D001TRC000Y2

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Pressure Monitoring Accessory EUDAMED
TruWave GUDID
Generic name
Blood pressure transducer holder
Model / Ref / Catalog
MP111
Primary DI / UDI-DI
07460691956148
Basic UDI-DI
0690103D001TRC000Y2
510(k) Number
FDA product code
FOX
EMDN code
Z12030299 Vital signs monitoring instruments - other
GMDN term
Blood pressure transducer holder
Device class
Class I
Regulation number
880.6990
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood pressure transducer holder

Cleared under the same submission (K925638)

Similar devices in this category

Other devices filed under VITAL SIGNS MONITORING INSTRUMENTS - OTHER.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)