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Captiflex M00562420

by Boston Scientific

Ref M00562420

Captiflex M00562420 is a device classified as Class IIb in the EU and Class II in the US made by Boston Scientific, registered in EUDAMED on 31 Oct 2025 (Basic UDI-DI 01915060000000000000049MW) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08714729747956), 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 Number01915060000000000000049MW Basic UDI-DI 08714729747956UDI-DIDate31 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729747956 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01915060000000000000049MW registered 31 Oct 2025 Active
  • FDA GUDID UDI-DI 08714729747956 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08714729747956
  2. Registered EUDAMED 01915060000000000000049MW

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  • Withdrawn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
Captiflex™ EUDAMED
Captiflex GUDID
Generic name
Mechanical-cutting endoscopic polypectomy snare
Device name
Captiflex Single-Use Polypectomy Snare
Model / reference
M00562420
Primary DI / UDI-DI
08714729747956
Basic UDI-DI
01915060000000000000049MW
FDA product code
FDI
EMDN code
G03030102 Polypectomy snares, non-revolving
GMDN term
Mechanical-cutting endoscopic polypectomy snare
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.4300
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Endoscopic electrosurgical handpiece/electrode, monopolar, single-useMechanical-cutting endoscopic polypectomy snare

Similar devices in this category

Other devices filed under POLYPECTOMY SNARES, NON-REVOLVING.

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)