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Cannulated Screw System + 04.353.685

by Tyber Medical

Ref 04.353.685

Cannulated Screw System + 04.353.685 is a device classified as Class IIb in the EU and Class II in the US made by Tyber Medical, registered in EUDAMED on 16 Mar 2026 (Basic UDI-DI 01964490165B) and listed in FDA GUDID since 8 May 2020 (UDI-DI 00810040636974), 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 Number01964490165B Basic UDI-DI 00810040636974UDI-DIDate16 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810040636974 UDI-DI Date8 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01964490165B registered 16 Mar 2026 Active
  • FDA GUDID UDI-DI 00810040636974 listed 8 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810040636974
  2. Registered EUDAMED 01964490165B

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  • Withdrawn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
Cannulated Screw System +
Generic name
Orthopaedic bone screw (non-sliding)
Device name
Screws
Model / Ref / Catalog
04.353.685
Primary DI / UDI-DI
00810040636974
Basic UDI-DI
01964490165B
FDA product code
HWC
EMDN code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER.

Other devices from Tyber Medical

See all devices from Tyber Medical →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)