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Dci™

by Paradigm Spine GmbH 2 variants

Ref CBT20500, CAC00000, CBT20000, CBT20100, CBT10002, CBT20110, CBT14165, CBT10125, CBT16185, CBT10126, CBT12147, CBT14166, CBT12146, CBT16187

Active European Union

CE MDR 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number0426014889005-006XS Basic UDI-DI Date17 Feb 2026RegisteredStatusActive
European UnionCE/MDR Number0426014889005-006XS Basic UDI-DI Date17 Feb 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  • Withdrawn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, CE/MDR Active

Specification

EUDAMED

Device Name
DCI™ distractor
DCI™ Sterilization tray
DCI™ inserter
DCI™ insertion instrument
DCI™ turning knob
DCI™ trial, 14x16x5
DCI™ trial, 10x12x5
DCI™ trial, 16x18x5
DCI™ trial, 10x12x6
DCI™ trial, 12x14x7
DCI™ trial, 14x16x6
DCI™ trial, 12x14x6
DCI™ trial, 16x18x7
Model / Reference
CBT20500, CAC00000, CBT20000, CBT20100, CBT10002, CBT20110, CBT14165, CBT10125, CBT16185, CBT10126, CBT12147, CBT14166, CBT12146, CBT16187
Primary DI / UDI-DI
04260148894114, 04260148890765, 04260148890772, 04260148890789, 04260148890635, 04260148894091, 04260148890703, 04260148890642, 04260148890734, 04260148890659, 04260148890697, 04260148890710, 04260148890680, 04260148890758
Basic UDI-DI
0426014889005-006XS, 0426014889005-001XG, 0426014889005-004XN, 0426014889005-003XL, 0426014889005-002XJ, B-04260148890703, B-04260148890642, B-04260148890734, B-04260148890659, B-04260148890697, B-04260148890710, B-04260148890680, B-04260148890758, 0426014889018-083M
Direct Marketing DI
04260148894114
04260148890765
04260148890772
04260148890789
04260148890635
04260148894091
04260148890710
04260148890680
04260148890697
04260148890659
04260148890734
04260148890758
04260148890642
04260148890703
EMDN Code
L091199, S010399
Device Class
Class I
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000011231

Other devices from Paradigm Spine GmbH

See all devices from Paradigm Spine GmbH →

Properties

  • Reusable YesEUDAMEDNoEUDAMED

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No