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Aptus A-3934S

by Medartis AG

Part of a family of 12 devices: see the family page

Ref A-3934S

Aptus A-3934S is a device classified as Class IIa in the EU and Class I in the US made by Medartis AG, listed in FDA GUDID since 1 Nov 2024 (UDI-DI 07630037856450), registry data as of 12 Nov 2026.

Listed No authorization on record

CE, no status data

Valid until

Not applicable

Database listing, no authorization

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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07630037856450 UDI-DI Date1 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Twist Drill Ø2.6mm x 70mm, L150mm, AO EUDAMED
Aptus GUDID
Generic name
Orthopaedic bur, single-use
Device name
Drills (sterile, non-sterile)
Model / Ref / Catalog
A-3934S
Primary DI / UDI-DI
07630037856450
Basic UDI-DI
76308948011US
FDA product code
HTW
EMDN code
Z12130503 Orthopaedic surgical drills
GMDN term
Orthopaedic bur, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I 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 ORTHOPAEDIC SURGICAL DRILLS.

Other devices from Medartis AG

See all devices from Medartis AG →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)