Flexiva™

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref M006L8405910

by Boston Scientific Corporation

Identity

Trade Name: Flexiva™ EUDAMED
Flexiva Pulse FDA UDI
Generic Name: General/multiple surgical laser system beam guide, single-use FDA UDI
Device Name: Flexiva Pulse EUDAMED
Flexiva Pulse and Flexiva Pulse TracTip laser fibers are high power single-use FDA UDI
Model / Reference: M006L8405910 EUDAMEDFDA UDI
Description: Flexiva Pulse and Flexiva Pulse TracTip laser fibers are high power single-use FDA UDI

Identifiers

Catalog Number: M006L8405910 FDA UDI
Primary DI / UDI-DI: 08714729978572 EUDAMEDFDA UDI
Basic UDI-DI: 01915060000000000000376NG 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

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 3.0 Meter FDA UDI

Category: Varicose vein lasing procedure kit

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

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Also classified as Varicose vein lasing procedure kit.

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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	01915060000000000000376NG	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

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

Sources (2)

EUDAMED 5c8b117c-91b1-4d5f-8ebd-6c3e726529f1 61 fields · synced May 30, 2026
FDA UDI cfbb5b7b-fe35-4f3c-9492-88f8d05cb2f9 35 fields · synced May 30, 2026