metene S BLOOD GLUCOSE MONITORING SYSTEM

GUDID 00850063675680

Lancet 50 Pcs Strip 50 Pcs Control solution 1 Bottle Lancing device 1 Pcs

METENE LIMITED

Glucose analyser IVD, home-use

• Primary Device ID: 00850063675680
• NIH Device Record Key: 218c1bb0-471a-4a64-922e-095ef3f338e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: metene S BLOOD GLUCOSE MONITORING SYSTEM
• Version Model Number: S
• Company DUNS: 117110707
• Company Name: METENE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850063675680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061181

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-08
• Device Publish Date: 2025-03-31

Devices Manufactured by METENE LIMITED

• 00850063675680 - metene S BLOOD GLUCOSE MONITORING SYSTEM: 2025-04-08Lancet 50 Pcs Strip 50 Pcs Control solution 1 Bottle Lancing device 1 Pcs
• 00850063675680 - metene S BLOOD GLUCOSE MONITORING SYSTEM: 2025-04-08 Lancet 50 Pcs Strip 50 Pcs Control solution 1 Bottle Lancing device 1 Pcs
• 00850048540798 - metene BLOOD GLUCOSE MONITORING SYSTEM: 2024-12-20 Lancet 150 Pcs Strip 150 Pcs Control solution 1 Bottle Lancing device 1 Pcs
• 00850009854018 - metene BLOOD GLUCOSE MONITORING SYSTEM: 2022-09-14 Lancet 100 Pcs Strip 100 Pcs Control solution 1 Bottle Lancing device 1 Pcs
• 00739810205885 - metene BLOOD GLUCOSE MONITORING SYSTEM: 2020-08-28
• 00739810207735 - metene Blood Glucose Test Strips (50pcs*2): 2019-08-27
• 00739810207742 - metene BLOOD GLUCOSE MONITORING SYSTEM: 2019-08-27