Identity
- Trade Name
- MOCACuff FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- MOCACuff (HL168KF) uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being’s wrist. All values can be read out in one LD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3~7.7 inch. The user is able to set the personal target value and the device will flash the value when the measured blood pressure value exceeds the target one. Further, HL168KF feature a built-in Bluetooth Data Transmission function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement. FDA UDI
- Model / Reference
- White (HL168KF) FDA UDI
- Description
- MOCACuff (HL168KF) uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being’s wrist. All values can be read out in one LD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3~7.7 inch. The user is able to set the personal target value and the device will flash the value when the measured blood pressure value exceeds the target one. Further, HL168KF feature a built-in Bluetooth Data Transmission function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850842006063 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
MOCACuff by Mocacare Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Mocacare Corp.
Sources (1)
- FDA UDI 229cf2cc-66a1-4fc5-928d-db69c918b0f1 34 fields · synced May 30, 2026