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ACS® Uni femoral resection guide anatomic 42161701

by implantcast GmbH

Ref 42161701Model KNU9URAGINST

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844KNU9URAGINST2Q Basic UDI-DI 04048844435165UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844435165 UDI-DI Date13 Sep 2021ListedStatusListed 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  • Withdrawn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
Acs® Uni EUDAMED
ACS® Uni femoral resection guide anatomic GUDID
Generic Name
Orthopaedic implant aiming/guiding block, reusable
Model / Reference
42161701, KNU9URAGINST
Primary DI / UDI-DI
04048844435165
Basic UDI-DI
4048844KNU9URAGINST2Q
Direct Marketing DI
04048844435165
FDA Product Code
HSX
EMDN Code
L0922 Orthopaedic surgery guides, reusable
GMDN Term
Orthopaedic implant aiming/guiding block, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3520
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 II

Related devices

Category: Orthopaedic implant aiming/guiding block, reusable

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Reusable
  • CMR Substance
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: 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