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Dominant Flex portable

by Medela LLC

Ref 071.0002

Dominant Flex portable (200.6295) is a device classified as Class IIa in the EU and Class II in the US made by Medela LLC, registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI 07612367ojntxmRG), cleared under FDA 510(k) K170329 on 24 Mar 2017 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07612367039635), active as of 7 Oct 2026. One FDA recall is 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

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170329

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Oct 2026.

Regulatory status

as of registry sync 7 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07612367ojntxmRG Basic UDI-DI 07612367039635UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170329 Date24 Mar 2017DecidedStatusActive
United StatesGUDID listing GUDID Number07612367039635 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 07612367ojntxmRG registered 1 Jul 2026 Active
  • FDA 510(k) K170329 decided 24 Mar 2017 Active· +2 more in the status table
  • FDA GUDID UDI-DI 07612367039635 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1502-2021 FDA Class II initiated 2 Dec 2020

    Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".

Timeline

6 dated events

  1. Cleared FDA 510(k) K130123
  2. Cleared FDA 510(k) K150134
  3. Listed FDA GUDID 07612367039635
  4. Cleared FDA 510(k) K170329
  5. Recall initiated FDA recalls Z-1502-2021
  6. Registered EUDAMED 07612367ojntxmRG

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  • Withdrawn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

Generic name
Surgical suction pump
Device name
Dominant Flex
Model / Ref / Catalog
071.0002 EUDAMED
Dominant Flex GUDID
200.6295 GUDID
Description
Powered suction pump 071.0002
Primary DI / UDI-DI
07612367039635
Basic UDI-DI
07612367ojntxmRG
Direct marketing DI
07612367089647
510(k) Number
FDA product code
BTA, HDB, MUU, QPB
EMDN code
Z120105 Surgical medical aspirators
GMDN term
Surgical suction pump
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4780, 884.4340, 878.5040
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
071.0002
GUDID
Dominant Flex
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Surgical suction pump

Cleared under the same submission (K130123)

and 8 more cleared under K130123

Cleared under the same submission (K150134)

and 8 more cleared under K150134

Similar devices in this category

Other devices filed under SURGICAL MEDICAL ASPIRATORS.

Other devices from Medela LLC

See all devices from Medela LLC →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)