Acutus Medical, Inc.

Certificate 1000131095

Issued

Valid until: Aug 20, 2028

Certificate 1000131095 is a valid Technical documentation issued to Acutus Medical, Inc. and registered in EUDAMED. Valid until August 20, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 1000131095
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 02971000131095

Validity

Issued: Aug 21, 2023
Valid from: Aug 21, 2023
Valid until: Aug 20, 2028

Manufacturer

Manufacturer: Acutus Medical, Inc.
Manufacturer SRN: US-MF-000019413
Manufacturer country: United States

Notified body

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

Covered devices

Linked SSCPs

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III2

2 scopes

AcQGuide Flex Catheter Introducer Set
Class III
0850027837FLEXX7
AcQGuide Mini Catheter Introducer Sets
Class III
00857042007MINIK5

Documents

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