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Mios

by Aesculap AG 28 variants

Part of a family of 34 devices: see the family page

Ref FK243R

Mios (FK243R) is a Class I device made by Aesculap AG, registered in EUDAMED on 16 Sep 2025 (Basic UDI-DI 403923900000038026) and listed in FDA GUDID since 23 Apr 2020 (UDI-DI 04038653456277), active (EUDAMED), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 Number403923900000038026 Basic UDI-DI 04038653456277UDI-DIDate16 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653456277 UDI-DI Date23 Apr 2020ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 403923900000038026 registered 16 Sep 2025 Active
  • FDA GUDID UDI-DI 04038653456277 listed 23 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653456277
  2. Registered EUDAMED 403923900000038026

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  • Withdrawn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
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
MIOS retractor
Model / Ref / Catalog
FK243R
Primary DI / UDI-DI
04038653456277
Basic UDI-DI
403923900000038026
Direct marketing DI
04038653456277
FDA product code
GAD
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
Not 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 PROSTHETICS 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)