Identity
- Trade Name
- CareTouch FDA UDI
- Generic Name
- Glucose IVD, control FDA UDI
- Device Name
- CareTouch Glucose Control Solution FDA UDI
- Model / Reference
- CT2-3 FDA UDI
- Description
- CareTouch Glucose Control Solution FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810128750059 FDA UDI
- 510(k) Number
- K111456 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Glucose IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glucose IVD, control
CareTouch by Tianjin Empecs Medical Device Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose IVD, control.
- WowGoHealth Control Solution - GSH-BGM902 - Level 1 — GOLDEN SMART HOME TECHNOLOGY CORP. · Class I
- OneTouch Ultra Plus — Lifescan Europe · Class II
- TRUE METRIX — TRIVIDIA HEALTH, INC. · Class I
- Oh'Care Lite Smart Glucose control solution-Level 1 — OSANG HEALTHCARE Co., Ltd. · Class I
- TRUE FOCUS — TRIVIDIA HEALTH, INC. · Class I
- Tyson Bio HS100 Control Solution (Level 1) — TYSON BIORESEARCH INC. · Class II
- ACCU-CHEK Inform II — Roche Diagnostics Operations, Inc. · Class I
- Assure® Prism Control Solution — ARKRAY USA, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tianjin Empecs Medical Device Co., Ltd.
Sources (1)
- FDA UDI 612e05ae-6b0f-4f83-b29f-6657866b1aaa 36 fields · synced May 30, 2026