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Elation™

by Biosphere Medical SA 2 variants

Ref EPCB8/AModel Elation™

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00884450399453 Basic UDI-DI 00884450399453UDI-DIDate3 Nov 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  • Withdrawn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
Elation 3-Stage Wire Guided Dilation Balloon
Model / Reference
Elation™, EPCB8/A
Primary DI / UDI-DI
00884450399453
Basic UDI-DI
B-00884450399453
EMDN Code
G0301010102 Oesophageal balloon catheters, high pressure
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
FR-MF-000005250

Other devices from Biosphere Medical SA

See all devices from Biosphere Medical SA →

Properties

  • Sterile
  • Animal Tissues

Other properties (9)

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