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metene BLOOD GLUCOSE MONITORING SYSTEM 150 TD-4116

by Metene Limited

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 Number00850048540781 UDI-DI Date7 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  • Withdrawn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
metene BLOOD GLUCOSE MONITORING SYSTEM 150
Generic Name
Glucose analyser IVD, home-use
Model / Reference
TD-4116
Description
Lancet 150 Pcs Strip 150 Pcs Control solution 1 Bottle Lancing device 1 Pcs
Primary DI / UDI-DI
00850048540781
510(k) Number
FDA Product Code
NBW
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 (K151100)

Other devices from Metene Limited

See all devices from Metene Limited →

Properties

  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (11)

  • 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
  • Manufacturing Date: No