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coflex®

by Paradigm Spine GmbH 10 variants

Ref UAT20110

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0426014889001-006WE Basic UDI-DI 04260148890147UDI-DIDate24 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260148890147 UDI-DI Date29 Jun 2017ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
coflex® EUDAMED
coflex Mallet cap GUDID
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Name
coflex® Mallet
Model / Reference
UAT20110
Primary DI / UDI-DI
04260148890147
Basic UDI-DI
0426014889001-006WE
Direct Marketing DI
04260148890147
PMA Number
FDA Product Code
NQO
EMDN Code
L0903 Orthopaedic surgery hammers, reusable
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class I EUDAMED
Class III GUDID
EU market of registration
Germany
GUDID distribution status
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 III

Manufacturer details

EUDAMED SRN
DE-MF-000011231

Other devices from Paradigm Spine GmbH

See all devices from Paradigm Spine GmbH →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • 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