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TheraSphere Y90 Glass Microspheres 16.5 GBq 990700.SPE

by Biocompatibles UK Ltd

Ref OTT-SPE-FP-700Model TheraSphere Yttrium-90 Glass Microspheres – 16.5 GBq

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn CE AIMDD, withdrawn

Ended

Withdrawn

Date not published (CE AIMDD, CE MDD)

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD EUDAMED NumberB-05060116920567 Basic UDI-DI 05060116920567UDI-DIDate8 Jun 2026RegisteredStatusWithdrawn
European UnionCE/MDD EUDAMED NumberB-05060116920567 Basic UDI-DI 05060116920567UDI-DIDate8 Jun 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number05060116920567 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  • Withdrawn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  • European Union CE/AIMDD, CE/MDD Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
TheraSphere Y90 Glass Microspheres 16.5 GBq
Generic Name
Manual brachytherapy source, permanent implant
Model / Reference
TheraSphere Yttrium-90 Glass Microspheres – 16.5 GBq EUDAMED
OTT-SPE-FP-700 EUDAMED
990700.SPE GUDID
Primary DI / UDI-DI
05060116920567
Basic UDI-DI
B-05060116920567
FDA Product Code
NAW
EMDN Code
J0501 Brachytherapy sources
GMDN Term
Manual brachytherapy source, permanent implant
Device Class
Class AIMDD EUDAMED
Class III GUDID
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
TheraSphere Yttrium-90 Glass Microspheres – 16.5 GBq
OTT-SPE-FP-700
GUDID
990700.SPE
Device ClassEUDAMED
Class AIMDD
GUDID
Class III

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • 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
  • Serial Number: No
  • Manufacturing Date: No