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Verticale

by Silony Medical GmbH 137 variants

Part of a family of 35 devices: see the family page

Ref VI-7128

Verticale (VI-7128) is a device classified as Class I in the EU and Class II in the US made by Silony Medical GmbH, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 4054896AWLER) and listed in FDA GUDID since 30 Jul 2026 (UDI-DI 04054896091013), 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
United StatesGUDID listing GUDID Number04054896091013 UDI-DI Date30 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4054896AWLER Basic UDI-DI 04054896091013UDI-DIDate21 May 2026RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4054896AWLER registered 21 May 2026 Active
  • FDA GUDID UDI-DI 04054896091013 listed 30 Jul 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 4054896AWLER
  2. Listed FDA GUDID 04054896091013

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  • Withdrawn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
Bone awl, reusable
Device name
Awl
Model / Ref / Catalog
VI-7128
Primary DI / UDI-DI
04054896091013
Basic UDI-DI
4054896AWLER
FDA product code
OLO
EMDN code
L091102 Orthopaedic prostheses reamers and burs, reusable
GMDN term
Bone awl, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
DE-MF-000006463

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE.

Other devices from Silony Medical GmbH

See all devices from Silony Medical GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)