Skip to content
UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

WATCHMAN FLX™

UDI-DI 00191506004644Basic UDI-DI 01915060000000000000569NV

Class III · MDR · Boston Scientific Corporation

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

MDR 813080

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-09-11 · Expiry 2030-06-17

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Boston Scientific Corporation

SRN US-MF-000004702

US · Marlborough

manufacturer

Authorised representative: Boston Scientific Limited (IE-AR-000003840)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/watchman-flxtm-4644 · UDI page: /udi/00191506004644

Scan an inventory CSV