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Nurochek-Pro Kit (HS03-369) rev 1

by Headsafe Mfg Pty, Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09357225000034 UDI-DI Date15 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Nurochek-Pro
Generic Name
Evoked-potential graphic recording system
Model / Ref / Catalog
Nurochek-Pro Kit (HS03-369) rev 1, HS03-369
Primary DI / UDI-DI
09357225000034
510(k) Number
FDA Product Code
OMC, PIW
GMDN Term
Evoked-potential graphic recording system
Device Class
Class II
Regulation Number
882.1400, 882.1450
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243426)

Other devices from Headsafe Mfg Pty, Ltd.

See all devices from Headsafe Mfg Pty, Ltd. →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No