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Aesculap

by Aesculap AG 1,000+ variants

Part of a family of 16 devices: see the family page

Ref FK350R

Aesculap (FK350R) is a Class I device made by Aesculap AG, registered in EUDAMED on 8 Oct 2025 (Basic UDI-DI 403923900000033623) and listed in FDA GUDID since 22 Apr 2020 (UDI-DI 04038653166343), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number403923900000033623 Basic UDI-DI 04038653166343UDI-DIDate8 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653166343 UDI-DI Date22 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 403923900000033623 registered 8 Oct 2025 Active
  • FDA GUDID UDI-DI 04038653166343 listed 22 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653166343
  2. Registered EUDAMED 403923900000033623

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  • Withdrawn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
Bone file/rasp, manual, reusable
Device name
Dissector
Model / Ref / Catalog
FK350R
Primary DI / UDI-DI
04038653166343
Basic UDI-DI
403923900000033623
Direct marketing DI
04038653166343
FDA product code
HTR
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

Manufacturer details

EUDAMED SRN
DE-MF-000005504

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY RASPS, REUSABLE.

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

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