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TSX® Bone Taps

by ZimVie US Corp LLC 2 variants

Ref TSXTAP31

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number844868CAHW Basic UDI-DI 00844868047261UDI-DIDate30 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00844868047261 UDI-DI Date21 Jan 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
TSX® Bone Taps EUDAMED
Tsx® GUDID
Generic Name
Bone tap, reusable
Device Name
Sterile Powered Surgically Invasive Instrument – Intended for Reprocessing
Model / Ref / Catalog
TSXTAP31
Description
TSX® BONE TAP, 3.1MM(D)
Primary DI / UDI-DI
00844868047261
Basic UDI-DI
844868CAHW
FDA Product Code
NDP
EMDN Code
L159099 Odontostomatology instruments, reusable - other
GMDN Term
Bone tap, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3980
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Width — 3.1 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000048255
Authorised representative
ZimVie Spain S.L.U. ES-AR-000000983

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Sterile
  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No