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K-Wire Spreader for Ø2.0mm

by Medartis AG

Ref A-2056

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300378009PJ Basic UDI-DI Date22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630037833031 UDI-DI Date24 Feb 2023ListedStatusListed 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.

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  • Withdrawn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
K-Wire Spreader for Ø2.0mm EUDAMED
Aptus GUDID
Generic Name
General internal orthopaedic fixation system implantation kit
Device Name
Retracting & repositioning Instruments
Model / Ref / Catalog
A-2056
Primary DI / UDI-DI
07630037833031, 07630037873037, 07630894829062
Basic UDI-DI
76300378009PJ
FDA Product Code
LXH
EMDN Code
L99 Surgical instruments, reusable - other
GMDN Term
General internal orthopaedic fixation system implantation kit
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
CH-MF-000022291
Authorised representative
Medartis GmbH DE-AR-000005810

Related devices

Category: Surgical retraction system, reusable

Other devices from Medartis AG

See all devices from Medartis AG →

Properties

  • Reusable
  • Prescription Use YesGUDIDNoGUDID
  • Premarket Exempt
  • Lot / Batch Number YesGUDIDNoGUDID
  • Manufacturing Date

Other properties (19)

  • 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
  • Serial Number: No
  • Expiration Date: No