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CoLink Afx

by In2Bones, USA 30 variants

Ref P07 N1105

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 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08101755025342 Basic UDI-DI 00817906028386UDI-DIDate28 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817906028386 UDI-DI Date22 Oct 2018ListedStatusListed 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 25 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  • Withdrawn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

Generic Name
Surgical implant/trial-implant/sizer holder, reusable
Device Name
Ankle Fracture Non-Sterile Instruments (Trials), Active
Model / Ref / Catalog
P07 N1105
Primary DI / UDI-DI
00817906028386
Basic UDI-DI
08101755025342
510(k) Number
FDA Product Code
HWC, HRS
EMDN Code
L091104 Orthopaedic prostheses positioners, reusable
GMDN Term
Surgical implant/trial-implant/sizer holder, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3040, 888.3030
EU market of registration
Belgium
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 IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000023092
Authorised representative
Conmed Europe BV BE-AR-000035662

Related devices

Category: Orthopaedic implant impactor, reusable

Other devices from In2Bones, USA

See all devices from In2Bones, USA →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • 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