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Lifemotion Disposable Membrane Oxygenator-1000

by Lifemotion Medical Technology Co., Ltd. EUDAMEDGUDID

Active European Union and United States

Ref LM-BGEA-1000Model LM-BGEA-1000, LM-BGEA-500

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06974762682054 UDI-DIDate2 Jun 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number697476268-BGEA-DP Basic UDI-DIDate17 Apr 2025RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID

Trade Name
Lifemotion Disposable Membrane Oxygenator-1000 EUDAMED
Lifemotion GUDID
Generic Name
Extracorporeal membrane oxygenator
Model / Ref / Catalog
LM-BGEA-1000, LM-BGEA-500
Primary DI / UDI-DI
06974762682054 EUDAMED
06974762681019 GUDID
Basic UDI-DI
697476268-BGEA-DP
FDA Product Code
DTZ
EMDN Code
C03010102 Oxygenator kits
GMDN Term
Extracorporeal membrane oxygenator
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.4350
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06974762682054
GUDID
06974762681019
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000043705
Authorised representative
LIFEMOTION S.R.L. IT-AR-000029834

Other devices from Lifemotion Medical Technology Co., Ltd.

See all devices from Lifemotion Medical Technology Co., Ltd. →

Properties

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

Other properties (17)

  • 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