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B.braun 7102226

by B.Braun Avitum AG

Part of a family of 11 devices: see the family page

Ref 7102226

B.braun 7102226 is a device classified as Class IIb in the EU and Class II in the US made by B.Braun Avitum AG, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 40392390000016172M), cleared under FDA 510(k) K083460 on 18 Feb 2010 (1 earlier submission) and listed in FDA GUDID since 9 Aug 2015 (UDI-DI 04046963686680), active as of 9 Nov 2026. 8 FDA recalls are linked to it.

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

8 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083460

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000016172M Basic UDI-DI 04046963686680UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04046963686680 UDI-DI Date9 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083460 Date18 Feb 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 40392390000016172M registered 3 Nov 2026 Active
  • FDA 510(k) K083460 decided 18 Feb 2010 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04046963686680 listed 9 Aug 2015 Listed

Recalls

8 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0872-2022 FDA Class II initiated 28 Jan 2022
    • Terminated Z-0873-2022 FDA Class II initiated 28 Jan 2022

    Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.

  • 6 recalls, same reason

    • Terminated Z-1532-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1535-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1531-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1536-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1533-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1534-2016 FDA Class I initiated 1 Apr 2016

    Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Timeline

12 dated events

  1. Listed FDA GUDID 04046963686680
  2. Recall initiated FDA recalls Z-1532-2016
  3. Recall initiated FDA recalls Z-1535-2016
  4. Recall initiated FDA recalls Z-1531-2016
  5. Recall initiated FDA recalls Z-1536-2016
  6. Recall initiated FDA recalls Z-1533-2016
  7. Recall initiated FDA recalls Z-1534-2016
  8. Recall initiated FDA recalls Z-0872-2022
  9. Recall initiated FDA recalls Z-0873-2022
  10. Registered EUDAMED 40392390000016172M

2 earlier events are in the sections above.

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
Abpm EUDAMED
B.braun GUDID
Generic name
Haemodialysis system, institutional
Device name
Dialog+
Model / Ref / Catalog
7102226
Description
OPTION ABPM DIALOG+ SW9.XX
Primary DI / UDI-DI
04046963686680
Basic UDI-DI
40392390000016172M
510(k) Number
FDA product code
KDI
EMDN code
Z12090201 Haemodialysis equipment
GMDN term
Haemodialysis system, institutional
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.5860
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Haemodialysis system, institutional

Cleared under the same submission (K083460)

and 8 more cleared under K083460

Cleared under the same submission (K963440)

and 8 more cleared under K963440

Similar devices in this category

Other devices filed under HAEMODIALYSIS EQUIPMENT.

Other devices from B.Braun Avitum AG

See all devices from B.Braun Avitum AG →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (22, all answered No)