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APAS Independence

by Clever Culture Systems AG

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 Number09354646000001 UDI-DI Date23 Mar 2020ListedStatusListed 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  • Withdrawn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

Generic Name
Microbial culture plate imaging/analysis system IVD
Model / Ref / Catalog
A, AI-16001
Primary DI / UDI-DI
09354646000001
510(k) Number
FDA Product Code
PPU
GMDN Term
Microbial culture plate imaging/analysis system IVD
Device Class
Class II
Regulation Number
866.2190
GUDID distribution status
In Commercial Distribution

Related devices

Category: Microbial culture plate imaging/analysis system IVD

Cleared under the same submission (K183648)

Other devices from Clever Culture Systems AG

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

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