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Bioptimal Embolectomy Catheter

by Bioptimal International PTE. LTD. 17 variants

Ref EL3261Model EL3260 (Medline)

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08886483538870 Basic UDI-DI 08886483538870UDI-DIDate29 Jan 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Embolectomy Catheter
Model / Reference
EL3260 (Medline), EL3261
Primary DI / UDI-DI
08886483538870
Basic UDI-DI
B-08886483538870
EMDN Code
C019002 Embolectomy catheters
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
SG-MF-000010306
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Bioptimal International Pte. Ltd.

See all devices from Bioptimal International Pte. Ltd. →

Properties

  • Sterile
  • Contains Latex

Other properties (9)

  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No