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Screwdriver HexaDrive

by Oticon Medical AB

Ref 265497

Screwdriver HexaDrive (265497) is a surgical screwdriver (EU MDR Class I; FDA Class I; FDA product code LRC, Instrument, Ent Manual Surgical) made by Oticon Medical AB, registered in EUDAMED on 7 Jun 2024 (Basic UDI-DI 57121491002086) and listed in FDA GUDID since 14 Jun 2024 (UDI-DI 05712149027408), 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
United StatesGUDID listing GUDID Number05712149027408 UDI-DI Date14 Jun 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number57121491002086 Basic UDI-DI 05712149027408UDI-DIDate7 Jun 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 57121491002086 registered 7 Jun 2024 Active
  • FDA GUDID UDI-DI 05712149027408 listed 14 Jun 2024 Listed

Timeline

2 dated events

  1. Registered EUDAMED 57121491002086
  2. Listed FDA GUDID 05712149027408

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  • Withdrawn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
Surgical screwdriver, reusable
Model / Ref / Catalog
265497
Primary DI / UDI-DI
05712149027408
Basic UDI-DI
57121491002086
Direct marketing DI
05712149027415
FDA product code
LRC
EMDN code
L149099 ENT instruments, reusable - other
GMDN term
Surgical screwdriver, reusable
Device class
Class I
Regulation number
874.4420
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
SE-MF-000000724

Similar devices in this category

Other devices filed under ENT INSTRUMENTS, REUSABLE - OTHER.

Other devices from Oticon Medical AB

See all devices from Oticon Medical AB →

Properties

  • Sterilise before use
  • Reusable
  • Reprocessed single-use device
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)