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metene S BLOOD GLUCOSE MONITORING SYSTEM

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 Number00850063675956 UDI-DI Date24 Dec 2025ListedStatusListed 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  • Withdrawn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

Generic Name
Glucose analyser IVD, home-use
Model / Reference
S
Description
Lancet 100 Pcs Strip 100 Pcs Control solution 1 Bottle Lancing device 1 Pcs
Primary DI / UDI-DI
00850063675956
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 (K061181)

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