Identity
- Trade Name
- Easy Talk FDA UDI
- Generic Name
- Glucose analyser IVD, home-use/point-of-care, line-powered FDA UDI
- Device Name
- Easy Talk Blood Glucose Monitoring System(Glucose Meter) FDA UDI
- Model / Reference
- 6277(BYG62277HAD) FDA UDI
- Description
- Easy Talk Blood Glucose Monitoring System(Glucose Meter) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719871820148 FDA UDI
- FDA Product Code
- JJX FDA UDICGA FDA UDINBW FDA UDI
- GMDN Term
- Glucose analyser IVD, home-use/point-of-care, line-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI862.1345 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Easy Talk by Biotest Medical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biotest Medical Corporation
Sources (1)
- FDA UDI 1dc9c9b8-293e-41ef-ae63-609b8fc3a87e 34 fields · synced May 31, 2026