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8207000000

by Stryker Corp.

Ref 8207-000-000Model 08858251002448T2

8207000000 is a device classified as Class IIa in the EU and Class I in the US made by Stryker Corp., registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI 08858251002448T2) and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 07613327304398), 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 Number08858251002448T2 Basic UDI-DI 07613327304398UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327304398 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002448T2 registered 19 Oct 2026 Active
  • FDA GUDID UDI-DI 07613327304398 listed 24 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327304398
  2. Registered EUDAMED 08858251002448T2

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  • Withdrawn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
System 8
Generic name
Bone/joint surgical power tool motor, electric
Device name
Handpiece-Sternum Saw
Model / Ref / Catalog
08858251002448T2 EUDAMED
8207-000-000 EUDAMED
8207000000 GUDID
Primary DI / UDI-DI
07613327304398
Basic UDI-DI
08858251002448T2
Direct marketing DI
07613327304398
FDA product code
HWE
EMDN code
Z12059010 Sternotomes
GMDN term
Bone/joint surgical power tool motor, electric
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
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
08858251002448T2
8207-000-000
GUDID
8207000000
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/joint surgical power tool motor, electric

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

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