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Knee arthroscopy support 10-353

by Reison Medical AB

Ref 10-353

Knee arthroscopy support 10-353 is an external orthopaedic fixation system (EU MDR Class I; FDA Class I; FDA product code FWZ, Operating Room Accessories Table Tray) made by Reison Medical AB, registered in EUDAMED on 4 Jun 2026 (Basic UDI-DI 735011183ARTHR5S) and listed in FDA GUDID since 30 Apr 2022 (UDI-DI 07350111831431), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735011183ARTHR5S Basic UDI-DI 07350111831431UDI-DIDate4 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350111831431 UDI-DI Date30 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 735011183ARTHR5S registered 4 Jun 2026 Active
  • FDA GUDID UDI-DI 07350111831431 listed 30 Apr 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07350111831431
  2. Registered EUDAMED 735011183ARTHR5S

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  • Withdrawn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
Knee arthroscopy support
Generic name
External orthopaedic fixation system, reusable
Device name
Arthroscopy support
Model / reference
10-353
Primary DI / UDI-DI
07350111831431
Basic UDI-DI
735011183ARTHR5S
FDA product code
FWZ
EMDN code
P09120499 External bone fixation systems - other
GMDN term
External orthopaedic fixation system, reusable
Device class
Class I
Regulation number
878.4950
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: External orthopaedic fixation system, reusable

Similar devices in this category

Other devices filed under EXTERNAL BONE FIXATION SYSTEMS - OTHER.

Other devices from Reison Medical AB

See all devices from Reison Medical AB →

Properties

  • Implantable NoEUDAMEDYesGUDID
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)