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SpermFilter Stock Solution 100% USA SPF100-USA-0050

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 Number08719747531853 UDI-DI Date19 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  • Withdrawn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
SpermFilter Stock Solution 100% USA
Generic Name
IVF medium
Model / Reference
SPF100-USA-0050
Primary DI / UDI-DI
08719747531853
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 — 50 Milliliter

Related devices

Cleared under the same submission (K053494)

Show all (12)

Other devices from Gynotec.B.V.

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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