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Aesculap FL097R

by Aesculap AG

Part of a family of 22 devices: see the family page

Ref FL097R

Aesculap FL097R is a Class I device made by Aesculap AG, registered in EUDAMED on 16 Sep 2025 (Basic UDI-DI 4039239000000406ZU) and listed in FDA GUDID since 22 Apr 2020 (UDI-DI 04038653167180), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4039239000000406ZU Basic UDI-DI 04038653167180UDI-DIDate16 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653167180 UDI-DI Date22 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4039239000000406ZU registered 16 Sep 2025 Active
  • FDA GUDID UDI-DI 04038653167180 listed 22 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653167180
  2. Registered EUDAMED 4039239000000406ZU

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  • Withdrawn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
Orthopaedic chisel
Device name
Tamper
Model / Ref / Catalog
FL097R
Primary DI / UDI-DI
04038653167180
Basic UDI-DI
4039239000000406ZU
FDA product code
HXG
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Orthopaedic chisel
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

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)