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Neoss Implant System 64031

by Neoss AB

Ref 64031

Neoss Implant System 64031 is a Class I device made by Neoss AB, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 506044033N0046N9) and listed in FDA GUDID since 8 Oct 2015 (UDI-DI 05060440332838), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506044033N0046N9 Basic UDI-DI 05060440332838UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060440332838 UDI-DI Date8 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 506044033N0046N9 registered 13 May 2026 Active
  • FDA GUDID UDI-DI 05060440332838 listed 8 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060440332838
  2. Registered EUDAMED 506044033N0046N9

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  • Withdrawn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
Tack Positioning Instrument EUDAMED
Neoss Implant System GUDID
Generic name
Bone tack inserter, basic
Device name
Tack Tool
Model / Ref / Catalog
64031
Primary DI / UDI-DI
05060440332838
Basic UDI-DI
506044033N0046N9
Direct marketing DI
05060440332838
FDA product code
NDP
EMDN code
P01020180 Dental implants - accessories
GMDN term
Bone tack inserter, basic
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone tack inserter, basic

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Neoss AB

See all devices from Neoss AB →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)