Synaptive Medical Inc.

Certificate MDR 723819

Rev. R001Reissued

Valid until: Jun 16, 2031

Certificate MDR 723819 is a valid Quality management system issued to Synaptive Medical Inc. and registered in EUDAMED. Valid until June 16, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR 723819
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2797MDR 723819R001

Validity

Issued: Jun 11, 2026
Valid from: Jun 17, 2026
Valid until: Jun 16, 2031

Manufacturer

Manufacturer: Synaptive Medical Inc.
Manufacturer SRN: CA-MF-000010705
Manufacturer country: Canada

Notified body

Notified body
Notified body SRN: 2797
Notified body country: Netherlands

Covered devices

No specific devices are listed for this certificate.

Characteristics

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

History

Supersedes

MDR 723819SupplementedMar 5, 2026 → Jun 16, 2026

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa2Class I2Class IIb1

5 scopes

Modus Nav
Class IIb
Trackable Suction
Class IIa
Modus Plan
Class IIa
Tracking Array for BrainPath
Class I
Reusable Pointer Instruments
Class I

Documents

LanguagesEN