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Cannulated Screw System + 04.354.530

by Tyber Medical

Ref 04.354.530

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01964490165B Basic UDI-DI 00810040635663UDI-DIDate16 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810040635663 UDI-DI Date8 May 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
04.354.530
Primary DI / UDI-DI
00810040635663
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

Related devices

Category: Orthopaedic bone screw (non-sliding)

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)

  • Supplied sterile: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No