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FlexiCAP

by DEYMED Diagnostic s.r.o. 4 variants

FlexiCAP (62-913) is a Class II device made by DEYMED Diagnostic s.r.o., listed in FDA GUDID since 12 Jun 2023 (UDI-DI 08592566629136), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08592566629136 UDI-DI Date12 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name
Psychophysiological biofeedback system
Model / Ref / Catalog
L (59 – 63 cm, blue), 32 channels, layout 06, 62-913
Primary DI / UDI-DI
08592566629136
FDA product code
HCC
GMDN term
Psychophysiological biofeedback system
Device class
Class II
Regulation number
882.5050
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)