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Flexiva™

by Boston Scientific Corporation 7 variants

Ref M006L8405920

Flexiva™ (M006L8405920) is a device classified as Class IIa in the EU and Class II in the US made by Boston Scientific, registered in EUDAMED on 28 Oct 2025 (Basic UDI-DI 01915060000000000000376NG) and listed in FDA GUDID since 1 May 2021 (UDI-DI 08714729978589), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000376NG Basic UDI-DI 08714729978589UDI-DIDate28 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729978589 UDI-DI Date1 May 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01915060000000000000376NG registered 28 Oct 2025 Active
  • FDA GUDID UDI-DI 08714729978589 listed 1 May 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08714729978589
  2. Registered EUDAMED 01915060000000000000376NG

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  • Withdrawn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
Flexiva™ EUDAMED
Flexiva Pulse GUDID
Generic name
General/multiple surgical laser system beam guide, single-use
Model / Ref / Catalog
M006L8405920
Primary DI / UDI-DI
08714729978589
Basic UDI-DI
01915060000000000000376NG
FDA product code
GEX
EMDN code
Z12011085 Laser surgery instruments - consumables
GMDN term
General/multiple surgical laser system beam guide, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 2.6 Meter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Similar devices in this category

Other devices filed under LASER SURGERY INSTRUMENTS - CONSUMABLES.

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)