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CarbonMed Venus Ultimate-Hepa

by Carbon (Shenzhen) Medical Device 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 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974405095159 UDI-DI Date26 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
CarbonMed
Generic Name
General-purpose ultrasound imaging system
Model / Reference
Venus Ultimate-Hepa
Primary DI / UDI-DI
06974405095159
510(k) Number
FDA Product Code
IYN, IYO, ITX
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class II
Regulation Number
892.1550, 892.1560, 892.1570
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243298)

Other devices from Carbon (Shenzhen) Medical Device Co., Ltd.

See all devices from Carbon (Shenzhen) Medical Device Co., Ltd. →

Properties

  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • 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