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ROTEM® ex-tem®

by Tem Innovations GmbH

Ref 503-05

ROTEM® ex-tem® (503-05-US) is a device classified as IVD General (EU), Class II (US) made by Tem Innovations GmbH, registered in EUDAMED on 6 Aug 2026 (Basic UDI-DI B-04260160470242), cleared under FDA 510(k) K101533 on 10 Aug 2011 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04260160470242), active as of 25 Oct 2026. 5 FDA recalls are linked to it.

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 ongoing

5 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K101533

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-04260160470242 Basic UDI-DI 04260160470242UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260160470242 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK101533 Date10 Aug 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04260160470242 registered 6 Aug 2026 Active
  • FDA 510(k) K101533 decided 10 Aug 2011 Active
  • FDA GUDID UDI-DI 04260160470242 listed 16 Sep 2016 Listed

Recalls

5 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2485-2019 FDA Class II initiated 23 Jul 2019
    • Terminated Z-2487-2019 FDA Class II initiated 23 Jul 2019
    • Terminated Z-2486-2019 FDA Class II initiated 23 Jul 2019

    Prolonged clotting times

    • Terminated Z-0302-2017 FDA Class II initiated 13 Sep 2016

    Customers complained of low/empty reagent vials.

    • Terminated Z-1379-2015 FDA Class II initiated 23 Oct 2014

    Some of vials were found to be partially filled.

Timeline

8 dated events

  1. Cleared FDA 510(k) K101533
  2. Recall initiated FDA recalls Z-1379-2015
  3. Recall initiated FDA recalls Z-0302-2017
  4. Listed FDA GUDID 04260160470242
  5. Recall initiated FDA recalls Z-2485-2019
  6. Recall initiated FDA recalls Z-2487-2019
  7. Recall initiated FDA recalls Z-2486-2019
  8. Registered EUDAMED B-04260160470242

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
r ex-tem EUDAMED
Rotem® GUDID
Generic name
Multiple coagulation marker IVD, reagent
Model / Ref / Catalog
503-05 EUDAMED
ex-tem® GUDID
503-05-US GUDID
Primary DI / UDI-DI
04260160470242
Basic UDI-DI
B-04260160470242
510(k) Number
FDA product code
JPA
EMDN code
W0103020899 Haemostasis rt & poc - other
GMDN term
Multiple coagulation marker IVD, reagent
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
864.5425
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
503-05
GUDID
ex-tem®
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: Multiple coagulation factor IVD, reagent

Cleared under the same submission (K101533)

Similar devices in this category

Other devices filed under HAEMOSTASIS RAPID TESTS - RT & POC.

Other devices from Tem Innovations GmbH

  • ROTEM® in-tem®

    Class II

  • ROTEM® ap-tem®

    Class II

  • Rotem® Rotrol N

    Class II

  • ROTEM® sigma complete + hep

    Class II

See all devices from Tem Innovations GmbH →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • Near-patient testing
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)