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IntellaNav StablePoint™

by Boston Scientific Corporation

Ref M004RARC040

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000268NC Basic UDI-DI 00191506020408UDI-DIDate28 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00191506020408 UDI-DI Date29 Feb 2024ListedStatusListed 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.

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0699-2019 FDA Class III initiated 28 Nov 2018

    Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.

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  • Withdrawn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
IntellaNav StablePoint™ EUDAMED
IntellaNav StablePoint™ Cable GUDID
Generic Name
Electrical-only medical device connection cable, reusable
Device Name
Stablepoint Cable (Ses) 6 Ft
Model / Ref / Catalog
M004RARC040
Primary DI / UDI-DI
00191506020408
Basic UDI-DI
01915060000000000000268NC
Direct Marketing DI
00191506020408
PMA Number
FDA Product Code
OAD, OAE
EMDN Code
C020399 Cardiac tissue ablation devices - other
GMDN Term
Electrical-only medical device connection cable, reusable
Device Class
Class I EUDAMED
Class III GUDID
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 200 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class III

Manufacturer details

EUDAMED SRN
US-MF-000004702
Authorised representative
Boston Scientific Limited IE-AR-000003840

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Sterile
  • Reusable
  • Reprocessed
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Single Use: No
  • Implantable: No
  • Contains Latex: 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
  • Expiration Date: No