Easymax Tag Self-Monitoring Blood Glucose System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- EASYMAX® Tag Self Monitoring Blood Glucose System EUDAMED
- Device Name
- EASYMAX® Tag Self Monitoring Blood Glucose System EUDAMED
- Model / Reference
- EM Tag EUDAMED681.68 EUDAMED681.71 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04713945681680 EUDAMED04713945681710 EUDAMED
- Basic UDI-DI
- B-04713945681680 EUDAMEDB-04713945681710 EUDAMED
- 510(k) Number
- K201258 FDA 510(k)
- FDA Product Code
- NBW FDA 510(k)
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Market of Registration
- Greece EUDAMED
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
Yes
Near-Patient Testing
No
Professional Testing
No
Companion Diagnostics
No
Surgical Instrument
Yes
The Easymax Tag Self-Monitoring Blood Glucose System is a blood glucose meter designed for self-monitoring of blood glucose levels in diabetic patients. It falls under the category of in vitro diagnostic devices, specifically for clinical chemistry applications, and is intended for home use to provide real-time glucose readings from capillary blood samples.
The system is supplied as a single-use device, requiring no sterilisation, and is intended for use in non-clinical settings such as the home. It is authorised under FDA 510K clearance (Special, Substantially Equivalent) and IVDD compliance, with no MRI safety restrictions noted. The device operates with a designated product code (NBW) and is manufactured by EPS Bio Technology Corp., Taiwan.
Frequently asked questions
What types of patients is the Easymax Tag system designed to help monitor, and where can it be used?
The Easymax Tag Self-Monitoring Blood Glucose System is specifically designed for diabetic patients to track their blood glucose levels in real-time using capillary blood samples. It is intended for home use in non-clinical settings, such as a patient’s residence, rather than in hospital or clinical environments.
Is the Easymax Tag system reusable, or is it meant for single-use only?
The Easymax Tag system is supplied as a single-use device, meaning each meter is intended for one-time use by a single patient. This design eliminates the need for sterilization and reduces the risk of cross-contamination.
How is the Easymax Tag system authorized for use, and what regulatory pathways does it follow?
The Easymax Tag system has received FDA clearance under the 510(k) pathway, specifically classified as *Substantially Equivalent (Special)*, and complies with the In Vitro Diagnostic Device Directive (IVDD). It was reviewed by the FDA’s Clinical Chemistry (CH) advisory committee and is listed under product code NBW.
Does the Easymax Tag system require any special handling or storage conditions?
Since the Easymax Tag is a single-use, non-sterile device for home use, it does not require sterilization. However, proper storage conditions should be followed to maintain its functionality—typically, it should be kept in a cool, dry place away from direct sunlight until use, as with most blood glucose meters.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K201258 | Class II | Active |
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Manufacturer
- Manufacturer
- Eps Bio Technology Corp.
Sources (3)
- FDA 510(k) K201258 24 fields · synced Sep 18, 2026
- EUDAMED e100ab42-29d1-43f3-bdc7-0e50689efc65 61 fields · synced Jun 20, 2026
- EUDAMED 9942d12d-cecb-4074-913b-0db530ee3cb1 61 fields · synced Jul 19, 2026