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PeriFlux 6000 PF 6000

by Perimed, Inc.

PeriFlux 6000 PF 6000 is a device classified as Class IIa in the EU and Class II in the US made by Perimed, Inc., registered in EUDAMED on 27 Feb 2026 (Basic UDI-DI 7332834A0006FC), cleared under FDA 510(k) K152930 on 5 May 2016 and listed in FDA GUDID since 20 Oct 2021 (UDI-DI 07332834000066), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152930

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7332834A0006FC Basic UDI-DI 07332834000066UDI-DIDate27 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07332834000066 UDI-DI Date20 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK152930 Date5 May 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7332834A0006FC registered 27 Feb 2026 Active
  • FDA 510(k) K152930 decided 5 May 2016 Active
  • FDA GUDID UDI-DI 07332834000066 listed 20 Oct 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152930
  2. Listed FDA GUDID 07332834000066
  3. Registered EUDAMED 7332834A0006FC

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Pf 6000 EUDAMED
PeriFlux 6000 GUDID
Generic name
Laser Doppler blood flowmeter
Model / reference
PF 6000
Primary DI / UDI-DI
07332834000066
Basic UDI-DI
7332834A0006FC
Direct marketing DI
07332834000066
510(k) Number
FDA product code
DPW
EMDN code
C99 Cardiocirculatory devices - other
GMDN term
Laser Doppler blood flowmeter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2100
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Laser Doppler blood flowmeterTranscutaneous blood gas monitoring system

Cleared under the same submission (K152930)

and 6 more cleared under K152930

Similar devices in this category

Other devices filed under CARDIOCIRCULATORY DEVICES - OTHER.

Other devices from Perimed, Inc.

See all devices from Perimed, Inc. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)