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Tpx

by Stryker Instruments 2 variants

Ref 7200-009-000Model 08858250000486SB

Tpx (7200-009-000) is a Class I device made by Stryker Instruments, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 08858250000486SB) and listed in FDA GUDID since 13 Apr 2026 (UDI-DI 07613327654127), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000486SB Basic UDI-DI 07613327654127UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327654127 UDI-DI Date13 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000486SB registered 28 May 2026 Active
  • FDA GUDID UDI-DI 07613327654127 listed 13 Apr 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327654127
  2. Registered EUDAMED 08858250000486SB

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  • Withdrawn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
Surgical power tool hand-switch
Device name
TPX Handswitch
Model / Ref / Catalog
08858250000486SB, 7200-009-000, 7200009000
Primary DI / UDI-DI
07613327654127
Basic UDI-DI
08858250000486SB
Direct marketing DI
07613327654127
FDA product code
HWE, DZI
EMDN code
Z12019099 Various instruments for general and multidisciplinary surgery - other
GMDN term
Surgical power tool hand-switch
Device class
Class I
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 · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858250000486SB
7200-009-000
GUDID
7200009000

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 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER.

Other devices from Stryker Instruments

See all devices from Stryker Instruments →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)