Route 92 Medical, Inc.

Certificate 1000236584

Rev. 04Supplemented

Valid until: May 18, 2027

Certificate 1000236584 is a valid Quality management system issued to Route 92 Medical, Inc. and registered in EUDAMED. Valid until May 18, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 1000236584
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0297100023658404

Validity

Issued: May 16, 2025
Valid from: May 16, 2025
Valid until: May 18, 2027

Manufacturer

Manufacturer: Route 92 Medical, Inc.
Manufacturer SRN: US-MF-000007441
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 0297
Notified body country: Germany

Covered devices

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

170776070Quality management systemIssuedMay 19, 2022 → May 18, 2027

Scope coverage

Class III4

4 scopes

MDN 1203 - Vascular Guide-Catheter, Single Use
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III

Documents

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