Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

Prelude Roadster™

UDI-DI 00884450844281Basic UDI-DI 0884450BUDI386QA

Class III · MDR · Merit Medical Systems, Inc.

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Identification

Model: Prelude Roadster™
EMDN: C01020101
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

MDR 778246

EU technical documentation assessment · unknown

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

Valid from 2026-08-17 · Expiry 2029-05-02

Scope not stated in certificate data.

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

Manufacturer

Merit Medical Systems, Inc.

SRN US-MF-000001366

US · South Jordan, Utah

manufacturer

Authorised representative: Merit Medical Ireland Ltd (IE-AR-000001011)

Related UDI-DIs

Prelude Roadster™ 00884450843864
Prelude Roadster™ 00884450843857
Prelude Roadster™ 00884450844236
Prelude Roadster™ 00884450843840
Prelude Roadster™ 00884450844038
Prelude Roadster™ 00884450843833
Prelude Roadster™ 00884450843680
Prelude Roadster™ 00884450843697
Prelude Roadster™ 00884450843734
Prelude Roadster™ 00884450843710
Prelude Roadster™ 00884450844212
Prelude Roadster™ 00884450844380

Showing 12 of 28 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/prelude-roadstertm-4281 · UDI page: /udi/00884450844281

All devices from Merit Medical Systems, Inc.

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