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Polaris™ Loop M0061552500

by Boston Scientific

Ref M0061552500

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

CE MDR

Valid until

7 Dec 2028

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000421MU Basic UDI-DI 08714729421184UDI-DIDate15 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729421184 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3827895TD05 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    15 Oct 2024
    Expires
    7 Dec 2028
    Reason
    Change approved

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  • Withdrawn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™ Loop GUDID
Generic Name
Polymeric ureteral stent
Device Name
Polaris Loop Ureteral Stent
Model / Ref / Catalog
M0061552500
Primary DI / UDI-DI
08714729421184
Basic UDI-DI
01915060000000000000421MU
FDA Product Code
FAD
EMDN Code
U020302 Double loop ureteral stents
GMDN Term
Polymeric ureteral stent
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.4620
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

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
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No