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CoFix™

by Paradigm Spine GmbH Germany EUDAMEDGUDID

Ref RAT20101

Product code KWPEMDN L091103

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0426014889002-004WM Basic UDI-DIDate16 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260148897665 UDI-DIDate29 Jun 2017ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

1 recall · FDA

    • Terminated Z-0412-2013 FDA Class II initiated 28 Aug 2012

    Inspan Compressors may break at weld causing a loss of compression

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
CoFix™ EUDAMED
coflex-F Punching pliers with guiding GUDID
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Name
coflex-F™ Punching Pliers
Model / Reference
RAT20101
Primary DI / UDI-DI
04260148897665
Basic UDI-DI
0426014889002-004WM
Direct Marketing DI
04260148897665
510(k) Number
FDA Product Code
KWP
EMDN Code
L091103 Orthopaedic prostheses forceps, reusable
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3050
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000011231

Other devices from Paradigm Spine GmbH

See all devices from Paradigm Spine GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
  • Prescription Use
  • Lot / Batch Number
Other properties (21)
  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 3a36d2d0-fa7e-4b60-8fb6-09ead4561f42 61 fields · synced 24 Oct 2026
  • FDA UDI f8bf18bf-640a-4d3f-b2dd-d622e76808f7 33 fields · synced 30 May 2026