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Tpx

by Stryker Instruments

Part of a family of 8 devices: see the family page

Ref 7200-008-000Model 08858251003726TE

Tpx (7200-008-000) is a device classified as Class IIa in the EU and Class I in the US made by Stryker Instruments, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 08858251003726TE) and listed in FDA GUDID since 13 Apr 2026 (UDI-DI 07613327652772), 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 Number08858251003726TE Basic UDI-DI 07613327652772UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327652772 UDI-DI Date13 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251003726TE registered 28 May 2026 Active
  • FDA GUDID UDI-DI 07613327652772 listed 13 Apr 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327652772
  2. Registered EUDAMED 08858251003726TE

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  • Withdrawn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

Generic name
Bone/joint surgical power tool motor, electric
Device name
Small Bone Handpieces - TPX
Model / Ref / Catalog
08858251003726TE, 7200-008-000, 7200008000
Primary DI / UDI-DI
07613327652772
Basic UDI-DI
08858251003726TE
Direct marketing DI
07613327652772
FDA product code
HWE, DZJ
EMDN code
Z12130599 Motorised orthopaedic surgery system instruments - other
GMDN term
Bone/joint surgical power tool motor, electric
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820, 872.4120
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251003726TE
7200-008-000
GUDID
7200008000
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.

Manufacturer details

EUDAMED SRN
US-MF-000025219
Authorised representative
Stryker European Operations Limited IE-AR-000000092

Similar devices in this category

Other devices filed under MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - OTHER.

Other devices from Stryker Instruments

See all devices from Stryker Instruments →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)