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Smart Toe XRP001002

by Stryker GmbH

Ref XRP001002Model 08858251002639TB

Smart Toe XRP001002 is a Class I device made by Stryker GmbH, registered in EUDAMED on 14 Jul 2026 (Basic UDI-DI 08858251002639TB) and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 07613252266556), 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 Number08858251002639TB Basic UDI-DI 07613252266556UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252266556 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002639TB registered 14 Jul 2026 Active
  • FDA GUDID UDI-DI 07613252266556 listed 24 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613252266556
  2. Registered EUDAMED 08858251002639TB

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  • Withdrawn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
Smart Toe® II EUDAMED
Smart Toe GUDID
Generic name
Bone file/rasp, manual, reusable
Device name
Smart Toe Instruments - Opening Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
XRP001002, 08858251002639TB
Primary DI / UDI-DI
07613252266556
Basic UDI-DI
08858251002639TB
Direct marketing DI
07613252266556
FDA product code
LXH
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Bone file/rasp, manual, reusable
Device class
Class I
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

Related devices

Category: Bone file/rasp, manual, reusable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)