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Lifemotion Standalone Oxygenator Holder

by Lifemotion Medical Technology Co., Ltd. China EUDAMEDGUDID

Ref LMF-13-001Model LM-BGEA-1000, LM-BGEA-500 Product code KRIEMDN C03010102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06974762682221 UDI-DIDate5 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 · synced 22 Oct 2026

Trade Name
Lifemotion Standalone Oxygenator Holder EUDAMED
Lifemotion GUDID
Generic Name
Extracorporeal membrane oxygenator
Device Name
Lifemotion Disposable Membrane Oxygenator
Model / Reference
LM-BGEA-1000, LM-BGEA-500, LMF-13-001
Primary DI / UDI-DI
06974762682221
Basic UDI-DI
697476268-BGEA-DP
FDA Product Code
KRI
EMDN Code
C03010102 Oxygenator kits
GMDN Term
Extracorporeal membrane oxygenator
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
870.4200
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
Contains LatexEUDAMED
No
GUDID
Yes

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 & raw data

Show properties, registry sources and raw records
  • Contains Latex NoEUDAMEDYesGUDID
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date
Other properties (18)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Expiration Date: No

Sources (2)

  • EUDAMED aa41a277-1ffc-4b38-b85f-b20d8db86a36 61 fields · synced 22 Oct 2026
  • FDA UDI dd77da28-a7da-459c-a070-5940af51b675 33 fields · synced 22 Oct 2026