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Hps™ 2.0

by Paradigm Spine GmbH 26 variants

Ref HBT40112

Active European Union

CE MDR

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 24 Oct 2026. What this means

Overview

The HPS™ 2.0 medical device is a sterilizable cannulated 'T' handle with ratchet designed for near-patient testing, sutures, and animal tissues. It features a user-friendly interface, precise measurements, and a reliable sterilization process. This device is manufactured by Paradigm Spine GmbH and complies with industry standards.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0426014889003-002WU Basic UDI-DI 04260636672361UDI-DIDate24 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
HPS™ Cannulated 'T' Handle with Ratchet
Model / Reference
HBT40112
Primary DI / UDI-DI
04260636672361
Basic UDI-DI
0426014889003-002WU
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
Device Class
Class I
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

  • Measuring Function

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • 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