Skip to content

Manual IsoLoader Kit

by Theragenics Corporation

Ref 10-05-1016-13Model Manual IsoLoader Kit

Active European Union

CE AIMDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD NumberB-00813787022192 Basic UDI-DI 00813787022192UDI-DIDate12 Aug 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  • Withdrawn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/AIMDD Active

Specification

EUDAMED

Device Name
Accessories
Model / Reference
Manual IsoLoader Kit, 10-05-1016-13
Primary DI / UDI-DI
00813787022192
Basic UDI-DI
B-00813787022192
EMDN Code
J0580 Implantable brachytherapy devices - accessories
Device Class
Class AIMDD
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000003014
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Theragenics Corp.

See all devices from Theragenics Corp. →

Properties

  • Sterile

Other properties (10)

  • Implantable: 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