Skip to content

Polaris™ Ultra M006192152090

by Boston Scientific

Ref M006192152090

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000064MS Basic UDI-DI 08714729124672UDI-DIDate25 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729124672 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Polaris™ EUDAMED
Polaris™ Ultra GUDID
Generic Name
Polymeric ureteral stent
Device Name
Polaris Ultra Side Holes Stent Set
Model / Reference
M006192152090
Primary DI / UDI-DI
08714729124672
Basic UDI-DI
01915060000000000000064MS
FDA Product Code
FAD
EMDN Code
V0599 Clinical procedures kits not included in other classes - other
GMDN Term
Polymeric ureteral stent
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.4620
Medical Purpose
Ureteral Stent Set
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Polymeric ureteral stent

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No