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MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer 010101003501

by Shenzhen New Industries Biomedical Engineering Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06947145541781 UDI-DI Date15 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
Generic Name
Chemiluminescent immunoassay analyser IVD
Model / Ref / Catalog
010101003501
Primary DI / UDI-DI
06947145541781
510(k) Number
FDA Product Code
JJE
GMDN Term
Chemiluminescent immunoassay analyser IVD
Device Class
Class I
Regulation Number
862.2160
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K232587)

Other devices from Shenzhen New Industries Biomedical Engineering Co., Ltd.

See all devices from Shenzhen New Industries Biomedical Engineering Co., Ltd. →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

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