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TheraSphere Administration Accessory Kit k125914-001

by Biocompatibles UK Ltd

Ref OTT-SPE-FP-617

Withdrawn Withdrawn in European Union.

Was authorized under CE AIMDD, withdrawn

Ended

Withdrawn

Date not published (CE AIMDD)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD EUDAMED NumberB-05060116920246 Basic UDI-DI 05060116920246UDI-DIDate22 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number05060116920246 UDI-DI Date24 Sep 2014ListedStatusListed GUDID: not in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/AIMDD Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
TheraSphere Administration Accessory Kit
Generic Name
Manual brachytherapy source, permanent implant
Model / Reference
OTT-SPE-FP-617 EUDAMED
k125914-001 GUDID
Primary DI / UDI-DI
05060116920246
Basic UDI-DI
B-05060116920246
FDA Product Code
NAW
EMDN Code
J0580 Implantable brachytherapy devices - accessories
GMDN Term
Manual brachytherapy source, permanent implant
Device Class
Class AIMDD EUDAMED
Class III GUDID
EU market of registration
Austria
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
OTT-SPE-FP-617
GUDID
k125914-001
Device ClassEUDAMED
Class AIMDD
GUDID
Class III
ImplantableEUDAMED
No
GUDID
Yes

Other devices from Biocompatibles UK Ltd

See all devices from Biocompatibles UK Ltd →

Properties

  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Serial Number

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No