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Sensor, HR/BVP FLEX/PRO SA9308M

by Thought Technology Ltd.

Part of a family of 16 devices: see the family page

Ref SA9308M

Sensor, HR/BVP FLEX/PRO SA9308M is a device classified as Class I in the EU and Class II in the US made by Thought Technology Ltd., registered in EUDAMED on 21 May 2026 (Basic UDI-DI 7540191000038V), cleared under FDA 510(k) K903497 on 12 Feb 1991 and listed in FDA GUDID since 31 Aug 2017 (UDI-DI 07540191000166), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K903497

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7540191000038V Basic UDI-DI 07540191000166UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07540191000166 UDI-DI Date31 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK903497 Date12 Feb 1991DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7540191000038V registered 21 May 2026 Active
  • FDA 510(k) K903497 decided 12 Feb 1991 Active
  • FDA GUDID UDI-DI 07540191000166 listed 31 Aug 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K903497
  2. Listed FDA GUDID 07540191000166
  3. Registered EUDAMED 7540191000038V

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  • Withdrawn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
BVP-Flex Pro EUDAMED
Sensor, HR/BVP FLEX/PRO GUDID
Generic name
Psychophysiological biofeedback system
Device name
ProComp family
Model / reference
SA9308M
Primary DI / UDI-DI
07540191000166
Basic UDI-DI
7540191000038V
510(k) Number
FDA product code
HCC
EMDN code
Z1203020408 Pulse oximeters
GMDN term
Psychophysiological biofeedback system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5050
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Psychophysiological biofeedback system

Cleared under the same submission (K903497)

and 8 more cleared under K903497

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

Other devices from Thought Technology Ltd.

See all devices from Thought Technology Ltd. →

Properties

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