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Screwdriver hexagon

by Oticon Medical AB

Ref M50534

Screwdriver hexagon (M50534) is a surgical screwdriver (EU MDR Class I; FDA Class II; FDA product code MAH, Hearing Aid, Bone Conduction, Implanted) made by Oticon Medical AB, registered in EUDAMED on 26 Apr 2022 (Basic UDI-DI 5712149100188K) and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05712149001026), 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 Number5712149100188K Basic UDI-DI 05712149001026UDI-DIDate26 Apr 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number05712149001026 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5712149100188K registered 26 Apr 2022 Active
  • FDA GUDID UDI-DI 05712149001026 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05712149001026
  2. Registered EUDAMED 5712149100188K

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  • Withdrawn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
Screwdriver hexagon EUDAMED
Ponto GUDID
Generic name
Surgical screwdriver, reusable
Model / Ref / Catalog
M50534
Primary DI / UDI-DI
05712149001026
Basic UDI-DI
5712149100188K
Direct marketing DI
05712149001026
FDA product code
MAH
EMDN code
L149099 ENT instruments, reusable - other
GMDN term
Surgical screwdriver, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.3302
EU registration type
Standard device
EU market of registration
Sweden
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
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
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)