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Fapon

by Guangdong Fapon Biotech Co. Ltd.,

Fapon is a Class I device made by Guangdong Fapon Biotech Co. Ltd.,, listed in FDA GUDID since 3 Feb 2024 (UDI-DI 06977159190002), registry data as of 31 May 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 31 May 2026.

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06977159190002 UDI-DI Date3 Feb 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Specimen stabilization reagent IVD
Model / reference
/
Primary DI / UDI-DI
06977159190002
FDA product code
PPM
GMDN term
Specimen stabilization reagent IVD
Device class
Class I
Regulation number
864.4010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Specimen stabilization reagent IVD

Similar devices

Other devices filed under FDA product code PPM (General Purpose Reagent).

Properties

  • Premarket exempt
Other properties (14, all answered No)