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Aesculap FK323R

by Aesculap, Inc.

Part of a family of 78 devices: see the family page

Ref FK323R

Aesculap FK323R is a Class I device made by Aesculap, Inc., registered in EUDAMED on 8 Oct 2025 (Basic UDI-DI 403923900000033929) and listed in FDA GUDID since 20 Apr 2020 (UDI-DI 04038653045242), active as of 25 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number403923900000033929 Basic UDI-DI 04038653045242UDI-DIDate8 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653045242 UDI-DI Date20 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 403923900000033929 registered 8 Oct 2025 Active
  • FDA GUDID UDI-DI 04038653045242 listed 20 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653045242
  2. Registered EUDAMED 403923900000033929

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  • Withdrawn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
Aesculap
Generic name
Bone file/rasp, manual, reusable
Device name
Elevator
Model / Ref / Catalog
FK323R
Primary DI / UDI-DI
04038653045242
Basic UDI-DI
403923900000033929
Direct marketing DI
04038653045242
FDA product code
GEG
EMDN code
L091201 Orthopaedic surgery rasps, reusable
GMDN term
Bone file/rasp, manual, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone file/rasp, manual, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY RASPS, REUSABLE.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)