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SpermWash USA SW-USA-0100

by Gynotec.B.V.

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 Number08719747531716 UDI-DI Date15 Jan 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  • Withdrawn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
SpermWash USA
Generic Name
IVF medium
Model / Reference
SW-USA-0100
Primary DI / UDI-DI
08719747531716
510(k) Number
FDA Product Code
MQL
GMDN Term
IVF medium
Device Class
Class II
Regulation Number
884.6180
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 100 Milliliter

Related devices

Cleared under the same submission (K242640)

Other devices from Gynotec.B.V.

See all devices from Gynotec.B.V. →

Properties

  • Sterile
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Single Use: 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