Skip to content

Percuflex™ Plus M0061755830

by Boston Scientific

Ref M0061755830

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000411MR Basic UDI-DI 08714729423461UDI-DIDate15 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729423461 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 AmericaNorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

EU market availability

Made available in 32 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 8 Dec 2025
  • Belgium since 8 Dec 2025
  • Bulgaria since 8 Dec 2025
  • Croatia since 8 Dec 2025
  • Cyprus since 8 Dec 2025
  • Czechia since 8 Dec 2025
  • Denmark since 8 Dec 2025
  • Estonia since 8 Dec 2025
  • Finland since 8 Dec 2025
  • France since 8 Dec 2025
  • Germany since 8 Dec 2025
  • Greece since 8 Dec 2025
  • Hungary since 8 Dec 2025
  • Iceland since 8 Dec 2025
  • Ireland since 8 Dec 2025
  • Italy since 8 Dec 2025
  • Latvia since 8 Dec 2025
  • Liechtenstein since 8 Dec 2025
  • Lithuania since 8 Dec 2025
  • Luxembourg since 8 Dec 2025
  • Malta since 8 Dec 2025
  • Netherlands since 8 Dec 2025
  • Northern Ireland since 8 Dec 2025
  • Norway since 8 Dec 2025
  • Poland since 8 Dec 2025
  • Portugal since 8 Dec 2025
  • Romania since 8 Dec 2025
  • Slovakia since 8 Dec 2025
  • Slovenia since 8 Dec 2025
  • Spain since 8 Dec 2025
  • Sweden since 8 Dec 2025
  • Türkiye since 8 Dec 2025

Last checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Percuflex™ EUDAMED
Percuflex™ Plus GUDID
Generic Name
Polymeric ureteral stent
Device Name
Percuflex™ Plus Ureteral Stent
Model / Reference
M0061755830
Primary DI / UDI-DI
08714729423461
Basic UDI-DI
01915060000000000000411MR
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