← Back to catalogue

Smart Diabetes

FDA UDI

Class II (US FDA UDI)

by Value Providers Llc

Identity

Trade Name
Smart Diabetes FDA UDI
Generic Name
Blood glucose/blood pressure monitoring system, home-use FDA UDI
Device Name
Smart Diabetes Voice Glucose Monitor FDA UDI
Model / Reference
EHS-SDMK-V FDA UDI
Description
Smart Diabetes Voice Glucose Monitor FDA UDI

Identifiers

Primary DI / UDI-DI
00854067005238 FDA UDI
510(k) Number
K133260 FDA UDI
FDA Product Code
NBW FDA UDI
JQP FDA UDI
JJX FDA UDI
CGA FDA UDI
GMDN Term
Blood glucose/blood pressure monitoring system, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
862.2100 FDA UDI
862.1660 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Blood glucose/blood pressure monitoring system, home-useGlucose rapid test/blood pressure system analyser, point-of-care

Smart Diabetes by Value Providers Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose rapid test/blood pressure system analyser, point-of-care.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Value Providers Llc

Sources (1)

  • FDA UDI 28c7e4a3-c8c9-450f-99f1-52c152556782 35 fields · synced May 30, 2026