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Jagwire M00556460

by Boston Scientific

Part of a family of 25 devices: see the family page

Ref M00556460

Jagwire M00556460 is a device classified as Class IIa in the EU and Class II in the US made by Boston Scientific, registered in EUDAMED on 5 Dec 2025 (Basic UDI-DI 01915060000000000000527ND) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08714729747130), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000527ND Basic UDI-DI 08714729747130UDI-DIDate5 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729747130 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01915060000000000000527ND registered 5 Dec 2025 Active
  • FDA GUDID UDI-DI 08714729747130 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08714729747130
  2. Registered EUDAMED 01915060000000000000527ND

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  • Withdrawn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
Jagwire™ EUDAMED
Jagwire GUDID
Generic name
General-purpose non-vascular guidewire
Model / reference
M00556460
Primary DI / UDI-DI
08714729747130
Basic UDI-DI
01915060000000000000527ND
FDA product code
OCY
EMDN code
G0399 Digestive endoscopy devices - other
GMDN term
General-purpose non-vascular guidewire
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: General-purpose non-vascular guidewire

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY DEVICES - OTHER.

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

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