EU Manufacturer ๐Ÿ‡บ๐Ÿ‡ธ United States Active

Acutus Medical, Inc.

SRN: US-MF-000019413 ยท Faraday Ave. 2210, 92008 Carlsbad, United States
Basic UDI-DIs
4
Total Devices
24
On Market
24
Off Market
0
Certificates
6
Valid
3
Expiring < 6mo
0
Countries
17

Basic Information

Address
Faraday Ave. 2210, 92008 Carlsbad, United States

Regulatory Overview

Regulation
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Eu Mdr 4
Classification
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Eu Md Class 3 4

Certificate Health

Total
6
Valid
3
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
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Type Number Expiry Date Status
MDR Technical Documentation 170782485 Nov 14, 2027 Issued
MDR Technical Documentation 1000131095 Aug 20, 2028 Issued
MDR Technical Documentation 1000166386 Feb 21, 2029 Issued
MDR Technical Documentation 31619290 MDR2017P โ€”
MDR Technical Documentation 1000166386 โ€”
MDR Technical Documentation 170781996 โ€”

Market Presence

Devices from this manufacturer are available in 17 countries across Europe.

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ธ๐Ÿ‡ช Sweden

Device Portfolio

Name
AcQCross Qx Integrated Transseptal Dilator/Needle
AcQCross Qx Integrated Transseptal Dilator/Needle
AcQCross Qx Integrated Transseptal Dilator/Needle
AcQCross Qx Integrated Transseptal Dilator/Needle
AcQCross Qx Integrated Transseptal Dilator/Needle
AcQCross Qx Integrated Transseptal Dilator/Needle
AcQCross Qx Integrated Transseptal Dilator/Needle
AcQCross Qx Integrated Transseptal Dilator/Needle
AcQCross Qx Integrated Transseptal Dilator/Needle
AcQCross Qx Integrated Transseptal Dilator/Needle
AcQGuide Flex Catheter Introducer Sets
AcQMap 3D Imaging and Mapping Catheter
FlexCath Cross Transseptal Solution
FlexCath Cross Transseptal Solution
FlexCath Cross Transseptal Solution
FlexCath Cross Transseptal Solution
FlexCath Cross Transseptal Solution
FlexCath Cross Transseptal Solution
FlexCath Cross Transseptal Solution
FlexCath Cross Transseptal Solution
FlexCath Cross Transseptal Solution
FlexCath Cross Transseptal Solution
FlexCath Cross Transseptal Solution with Flex Sheath
FlexCath Cross Transseptal Solution with Mini Sheath