Flexiva™

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref M006L8406910

by Boston Scientific Corporation

Identity

Trade Name: Flexiva™ EUDAMED
Flexiva Pulse ID FDA UDI
Generic Name: General/multiple surgical laser system beam guide, single-use FDA UDI
Device Name: Flexiva Pulse ID EUDAMED
Flexiva Pulse and Flexiva Pulse TracTip laser fibers are high power single-use fiber FDA UDI
Model / Reference: M006L8406910 EUDAMEDFDA UDI
Description: Flexiva Pulse and Flexiva Pulse TracTip laser fibers are high power single-use fiber FDA UDI

Identifiers

Catalog Number: M006L8406910 FDA UDI
Primary DI / UDI-DI: 08714729978671 EUDAMEDFDA UDI
Basic UDI-DI: 01915060000000000000604N6 EUDAMED
FDA Product Code: GEX FDA UDI
EMDN Code: Z12011085 LASER SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
GMDN Term: General/multiple surgical laser system beam guide, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 3.0 Meter FDA UDI

Category: Varicose vein lasing procedure kit

Flexiva™ by Boston Scientific Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Varicose vein lasing procedure kit.

Bare Fiber — Ceram Optec SIA · Class IIa
Laser Surgery Fiber 550µm — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
Disposable Laser Surgery Fiber 550µm — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
Laser Surgery Fiber - Orthopaedic Surgery Fiber for PLDD — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
Laser Surgery Fiber - Radial Emission Fiber 600µm — OBERON GMBH FIBER TECHNOLOGIES · Class IIa
VenaCure EVLT — ANGIODYNAMICS, INC · Class II
Bare Fiber — CeramOptec GmbH · Class IIa
Laser Surgery Fiber - Disposable 600 micron laser fiber — OBERON GMBH FIBER TECHNOLOGIES · Class IIa

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	01915060000000000000604N6	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Boston Scientific Corporation
EUDAMED SRN: US-MF-000004702
Authorised Representative: Boston Scientific Limited IE-AR-000003840

Sources (2)

EUDAMED 77baec04-3350-4e00-8d6c-18ed79325417 61 fields · synced Jul 14, 2026
FDA UDI 1b3c07b0-1c37-4bf3-a734-3c99861392d1 35 fields · synced May 30, 2026