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NTAP685

by ZimVie US Corp LLC

Ref NTAP685

NTAP685 is a device classified as Class IIa in the EU and Class I in the US made by ZimVie US Corp LLC, registered in EUDAMED on 8 Jun 2026 (Basic UDI-DI 844868AEHY) and listed in FDA GUDID since 24 Mar 2016 (UDI-DI 00844868012351), 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
European UnionCE/MDR EUDAMED Number844868AEHY Basic UDI-DI 00844868012351UDI-DIDate8 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00844868012351 UDI-DI Date24 Mar 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 844868AEHY registered 8 Jun 2026 Active
  • FDA GUDID UDI-DI 00844868012351 listed 24 Mar 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00844868012351
  2. Registered EUDAMED 844868AEHY

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  • Withdrawn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
Bone Tap
Generic name
Bone tap, reusable
Device name
Non-Sterile powered surgically invasive instrument
Model / reference
NTAP685
Primary DI / UDI-DI
00844868012351
Basic UDI-DI
844868AEHY
FDA product code
NDP
EMDN code
Q0199 Odontology devices - other
GMDN term
Bone tap, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 8.5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Bone tap, reusable

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

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