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VIVO System

by Catheter Precision, Inc

Ref 9002-001

VIVO System (9002-001) is a cardiac mapping system application software (EU MDR Class I; FDA Class II; FDA product code DQK, Computer, Diagnostic, Programmable) made by Catheter Precision, Inc, registered in EUDAMED on 28 Feb 2024 (Basic UDI-DI 08514240079002-001VR), cleared under FDA 510(k) K200313 on 14 Sep 2020 (1 earlier submission) and listed in FDA GUDID since 3 Feb 2026 (UDI-DI 00851424007089), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200313↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00851424007089 UDI-DI Date3 Feb 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08514240079002-001VR Basic UDI-DI 00851424007089UDI-DIDate28 Feb 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK200313 Date14 Sep 2020IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08514240079002-001VR registered 28 Feb 2024 Active
  • FDA 510(k) K200313 decided 14 Sep 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00851424007089 listed 3 Feb 2026 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K183195
  2. Cleared FDA 510(k) K200313
  3. Registered EUDAMED 08514240079002-001VR
  4. Listed FDA GUDID 00851424007089

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
VIVO System EUDAMED
Vivo GUDID
Generic name
Cardiac mapping system application software
Model / Ref / Catalog
9002-001 EUDAMED
9002 GUDID
Primary DI / UDI-DI
00851424007089
Basic UDI-DI
08514240079002-001VR
Direct marketing DI
00851424007089
510(k) Number
FDA product code
DQK
EMDN code
V92 Medical device software - not included in other classes
GMDN term
Cardiac mapping system application software
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1425
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
9002-001
GUDID
9002
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000018898
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)