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Haier DW-86L578J

by Qingdao Haier Biomedical Co Ltd

Haier DW-86L578J is a Class II device made by Qingdao Haier Biomedical Co Ltd, listed in FDA GUDID since 4 Aug 2020 (UDI-DI 06949573517314), registry data as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06949573517314 UDI-DI Date4 Aug 2020ListedStatusListed 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  • Withdrawn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

Trade name
Haier
Generic name
Ultralow-temperature laboratory freezer
Model / Ref / Catalog
DW-86L578J
Primary DI / UDI-DI
06949573517314
FDA product code
KSE
GMDN term
Ultralow-temperature laboratory freezer
Device class
Class II
Regulation number
864.9700
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code KSE (Refrigerator, Freezer, Blood Storage).

Other devices from Qingdao Haier Biomedical Co Ltd

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)