Identity
- Trade Name
- CareTouch FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- Mixed Case: CareTouch Blood Glucose Monitoring System + CareTouch Blood Glucose Test Strip FDA UDI
- Model / Reference
- CTMK50 FDA UDI
- Description
- Mixed Case: CareTouch Blood Glucose Monitoring System + CareTouch Blood Glucose Test Strip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810128750134 FDA UDI
- 510(k) Number
- K111456 FDA UDI
- FDA Product Code
- CGA FDA UDINBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose monitoring system IVD, home-use
CareTouch by Tianjin Empecs Medical Device Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose monitoring system IVD, home-use.
- Gmate® Origin Blood Glucose Monitoring System — Philosys, Inc. · Class II
- One Drop — INFORMED DATA SYSTEMS INC. · Class II
- TRUE METRIX GO — TRIVIDIA HEALTH, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- ReliOn® Confirm/micro Blood Glucose Test Strips — Walmart Stores · Class II
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC. · Class II
- LEADER — Cardinal Health 110, Inc. · Class II
- CareSens N Voice Multi — i-SENS, Inc. · Class II
Cleared under the same submission
K111456 also covers:
- CareLiving MM1100 Blood Glucose Meter — CARE LIVING DIAGNOSTICS INC
- CareLiving MM1100 Blood Glucose Monitoring System — CARE LIVING DIAGNOSTICS INC
- CareLiving MM1100 Blood Glucose Test Strips 100ct — CARE LIVING DIAGNOSTICS INC
- CareLiving MM1100 Blood Glucose Test Strips 50ct — CARE LIVING DIAGNOSTICS INC
- CareLiving MM1100 Control Solution For Blood Glucose — CARE LIVING DIAGNOSTICS INC
- Care Touch — FUTURE DIAGNOSTICS LLC
- Care Touch — FUTURE DIAGNOSTICS LLC
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- Teco Diagnostics Glucopad Blood Glucose Test Strips — TECO DIAGNOSTICS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Tianjin Empecs Medical Device Co., Ltd.
Sources (1)
- FDA UDI fa9dfacb-ffad-4a8d-a4f6-099542340694 36 fields · synced May 30, 2026