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Hps™ 2.0

by Paradigm Spine GmbH 26 variants

Ref HBT40110, HBI92532, HBT90700, HBT60400, HBT40125, HBT40271, HBT00185, HBC00000, HBT90140, HBT80162, HBT40126, HBT90194, HBT80500, HBT90192, HBT40291, HBT80150, HBT40263, HBT90450, HBT90176, HBI81010, HBT90220, HBT90300, HBT40251, HBT80160, HBT50000, HBT90175, HBT80102, HBT90250, HBT90190, HBT40293, HBT50100, HBT40261, HBT40273, HBT80110, HBC30000, HBT90470, HBT40243, HBT40283, HCD80800Model HPS™ 2.0 Rod coupler, S=25N/mm, 32mm

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number0426014889003-002WU Basic UDI-DI Date24 Feb 2026RegisteredStatusActive
European UnionCE/MDR Number0426014889003-002WU Basic UDI-DI Date24 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  • Withdrawn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
HPS™ Cannulated 'T' Handle with Ratchet
HPS™ 2.0 Rod coupler
HPS™ Distractor
HPS™ 2.0 MIS Tulip sleeve
HPS™ 2.0 Tap, cannulated 4.5mm
HPS™ Torque wrench
HPS™ 2.0 Sterilization container
HPS™ 2.0 Measurement tool
HPS™ 2.0 Lock screw driver
HPS™ 2.0 Coupler template
HPS™ 2.0 Counter torque holder
HPS™ 2.0 Aligner
HPS™ 2.0 Vice grip
HPS™ 2.0 Set screw
HPS™ Bending pliers
HPS™ Rod cutter
HPS™ 2.0 Trocar awl
HPS™ 2.0 Polyaxial screwdriver
HPS™2.0 MIS Rod inserter
HPS™ Cement injection set
Model / Reference
HBT40110, HPS™ 2.0 Rod coupler, S=25N/mm, 32mm, HBI92532, HBT90700, HBT60400, HBT40125, HBT40271, HBT00185, HBC00000, HBT90140, HBT80162, HBT40126, HBT90194, HBT80500, HBT90192, HBT40291, HBT80150, HBT40263, HBT90450, HBT90176, HBI81010, HBT90220, HBT90300, HBT40251, HBT80160, HBT50000, HBT90175, HBT80102, HBT90250, HBT90190, HBT40293, HBT50100, HBT40261, HBT40273, HBT80110, HBC30000, HBT90470, HBT40243, HBT40283, HCD80800
Primary DI / UDI-DI
04260148899539, 04260148891656, 04260636672484, 04260148899676, 04260148899546, 04260636672064, 04260148899522, 04260636670251, 04260148899713, 04260636672132, 04260636672354, 04260636670244, 04260148899706, 04260636670237, 04260636672101, 04260636672125, 04260636672279, 04260148899775, 04260636672149, 04260636670404, 04260148899751, 04260636672231, 04260636672026, 04260148899690, 04260148899607, 04260636670220, 04260636670213, 04260636672156, 04260148899744, 04260636672330, 04260148899614, 04260636672040, 04260636672293, 04260636672385, 04260636670398, 04260636670190, 04260636672422, 04260636672316, 04260148899232
Basic UDI-DI
0426014889003-002WU, B-04260148891656, 0426014889003-014X3, 0426014889003-031X3, 0426014889003-005X2, 0426014889003-033X7, 0426014889003-001WS, 0426014889003-030WZ, 0426014889003-012WX, 0426014889003-027XC, 0426014889003-017X9, 0426014889003-011WV, 0426014889003-018XB, 0426014889003-019XD, B-04260636670404, 0426014889003-003WW, 0426014889003-004WY, 0426014889003-007X6, 0426014889003-010WT, 0426014889003-016X7, B-04260148899232
Direct Marketing DI
04260148899539
04260636672484
04260148899546
04260636672064
04260148899522
04260636670251
04260148899713
04260636672132
04260636672354
04260636670244
04260148899706
04260636670237
04260636672101
04260636672125
04260636672279
04260148899775
04260636672149
04260148899751
04260636672231
04260636672026
04260148899690
04260148899607
04260636670220
04260636670213
04260636672156
04260148899744
04260636672330
04260148899614
04260636672040
04260636672293
04260636672385
04260636670398
04260636670190
04260636672422
04260636672316
EMDN Code
L091199, P09070305, L1299, S010399, V030204, P09070302, P099002
Device Class
Class I
Class IIb
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

  • Sterile NoEUDAMEDYesEUDAMED
  • Implantable NoEUDAMEDYesEUDAMED
  • Reusable NoEUDAMEDYesEUDAMED
  • Measuring Function YesEUDAMEDNoEUDAMED

Other properties (9)

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