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Inzone M00345100950

by Stryker Corp.

Ref 451009-5Model 08858250000263RM

Inzone M00345100950 (451009-5) is a device classified as Class IIa in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI 08858250000263RM) and listed in FDA GUDID since 21 Sep 2015 (UDI-DI 04546540697950), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000263RM Basic UDI-DI 04546540697950UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540697950 UDI-DI Date21 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000263RM registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 04546540697950 listed 21 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540697950
  2. Registered EUDAMED 08858250000263RM

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  • Withdrawn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
Inzone
Generic name
Vascular implant detacher, electronic, single-use
Device name
InZone Detachment System
Model / Ref / Catalog
08858250000263RM, 451009-5, M00345100950
Primary DI / UDI-DI
04546540697950
Basic UDI-DI
08858250000263RM
FDA product code
KRD, HCG
EMDN code
C010404020280 Neurovascular embolisation devices - accessories
GMDN term
Vascular implant detacher, electronic, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.3300, 882.5950
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858250000263RM
451009-5
GUDID
M00345100950
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Vascular implant detacher, electronic, single-use

Similar devices in this category

Other devices filed under ANGIOGRAPHY AND HAEMODYNAMIC DEVICES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (19, all answered No)