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Aptus A-2031

by Medartis AG

Part of a family of 26 devices: see the family page

Ref A-2031

Aptus A-2031 is a Class I device made by Medartis AG, registered in EUDAMED on 22 Apr 2026 (Basic UDI-DI 76300378006PC) and listed in FDA GUDID since 24 Feb 2023 (UDI-DI 07630037872955), 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 Number76300378006PC Basic UDI-DI 07630037872955UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630037872955 UDI-DI Date24 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76300378006PC registered 22 Apr 2026 Active
  • FDA GUDID UDI-DI 07630037872955 listed 24 Feb 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630037872955
  2. Registered EUDAMED 76300378006PC

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  • Withdrawn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
2.0-2.8 Depth Gauge EUDAMED
Aptus GUDID
Generic name
General internal orthopaedic fixation system implantation kit
Device name
Gauges
Model / Ref / Catalog
A-2031
Primary DI / UDI-DI
07630037872955
Basic UDI-DI
76300378006PC
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 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: General internal orthopaedic fixation system implantation kit

Similar devices in this category

Other devices filed under SURGICAL INSTRUMENTS, REUSABLE - OTHER.

Other devices from Medartis AG

See all devices from Medartis AG →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)