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LensHooke Semen Test Slide CS3-01 Package-25pcs-US-BR

by Bonraybio 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 Number14719874743519 UDI-DI Date6 Feb 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  • Withdrawn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
LensHooke Semen Test Slide
Generic Name
Microscope counting chamber IVD
Model / Ref / Catalog
CS3-01 Package-25pcs-US-BR, CS3-01 10um
Primary DI / UDI-DI
14719874743519
510(k) Number
FDA Product Code
POV
GMDN Term
Microscope counting chamber IVD
Device Class
Class II
Regulation Number
864.5220
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K242388)

Other devices from Bonraybio Co., Ltd.

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No