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TrueView Core 100Pro-US

by CompAI MedTech (Suzhou) Co., 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 Number06979294740036 UDI-DI Date22 Jul 2026ListedStatusListed 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  • Withdrawn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
TrueView
Generic Name
Tissue specimen x-ray system IVD
Model / Reference
Core 100Pro-US
Primary DI / UDI-DI
06979294740036
510(k) Number
FDA Product Code
MWP
GMDN Term
Tissue specimen x-ray system IVD
Device Class
Class II
Regulation Number
892.1680
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K230140)

Other devices from CompAI MedTech (Suzhou) Co., Ltd.

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No