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Identity™ SBHA4045

by Zimmer, Inc.

Ref SBHA4045

Identity™ SBHA4045 is a device classified as Class IIa in the EU and Class I in the US made by Zimmer, Inc., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI 889024BQC2G) and listed in FDA GUDID since 22 Sep 2022 (UDI-DI 00889024628076), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024BQC2G Basic UDI-DI 00889024628076UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024628076 UDI-DI Date22 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024BQC2G registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI 00889024628076 listed 22 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024628076
  2. Registered EUDAMED 889024BQC2G

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  • Withdrawn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
Identity™
Generic name
Bone file/rasp, manual, reusable
Device name
IDENTITY Resection Planers
Model / Ref / Catalog
SBHA4045
Primary DI / UDI-DI
00889024628076
Basic UDI-DI
889024BQC2G
FDA product code
HTO
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Bone file/rasp, manual, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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.

Related devices

Category: Bone file/rasp, manual, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

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