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9801-45

by Zimmer, Inc.

Ref 00-9801-045-00

9801-45 (00-9801-045-00) is a device classified as Class IIa in the EU and Class I in the US made by Zimmer, Inc., registered in EUDAMED on 31 Oct 2026 (Basic UDI-DI B-00889024156746) and listed in FDA GUDID since 25 Jul 2016 (UDI-DI 00889024156746), active as of 7 Nov 2026.

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

CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00889024156746 Basic UDI-DI 00889024156746UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024156746 UDI-DI Date25 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00889024156746 registered 31 Oct 2026 Active
  • FDA GUDID UDI-DI 00889024156746 listed 25 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024156746
  2. Registered EUDAMED B-00889024156746

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Centralign Precoat Hip Instrumentation
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Versys Taper Reamer
Model / Ref / Catalog
00-9801-045-00, 9801-45
Primary DI / UDI-DI
00889024156746
Basic UDI-DI
B-00889024156746
FDA product code
HTO
EMDN code
L091102 Orthopaedic prostheses reamers and burs, reusable
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
00-9801-045-00
GUDID
9801-45
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.

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)