Skip to content

metene Blood Glucose Test Strips (50pcs*2) TD-4116

by Metene Limited 2 variants

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 Number00850078311412 UDI-DI Date15 Jul 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  • Withdrawn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
metene Blood Glucose Test Strips (50pcs*2)
Generic Name
Glucose analyser IVD, home-use
Model / Reference
TD-4116
Primary DI / UDI-DI
00850078311412
510(k) Number
FDA Product Code
CGA
GMDN Term
Glucose analyser IVD, home-use
Device Class
Class II
Regulation Number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K090188)

Other devices from Metene Limited

See all devices from Metene Limited →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: 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
  • Serial Number: No
  • Manufacturing Date: No