Identity
- Trade Name
- Andesfit FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Model / Reference
- U81E FDA UDI
Identifiers
- Catalog Number
- Yes FDA UDI
- Primary DI / UDI-DI
- 06953825906887 FDA UDI
- 510(k) Number
- K243115 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Andesfit by Shenzhen Urion Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automatic-inflation electronic sphygmomanometer, portable, arm/wrist.
- Arm Type Automatic Blood Pressure Monitor — Shenzhen Jiacom Technology Co., Ltd · Class II
- Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System — DARIOHEALTH CORP. · Class II
- Veridian Healthcare — VERIDIAN HEALTHCARE · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- RemoteCare 4U — Guangdong Transtek Medical Electronics Co., Ltd · Class II
- Omron 3 Series Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc. · Class II
- NURSAL — Shenzhen Jamr Medical Technology Co., Ltd. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
Cleared under the same submission
K243115 also covers:
- ALPHAGOMED — Shenzhen Urion Technology Co., Ltd.
- ALPHAMED — Shenzhen Urion Technology Co., Ltd.
- ALPHAMED — Shenzhen Urion Technology Co., Ltd.
- AQESO — Shenzhen Urion Technology Co., Ltd.
- AQESO — Shenzhen Urion Technology Co., Ltd.
- AccuCare — Shenzhen Urion Technology Co., Ltd.
- AlphaMed — Shenzhen Urion Technology Co., Ltd.
- AlphaMed — Shenzhen Urion Technology Co., Ltd.
- AlphagoMed — Shenzhen Urion Technology Co., Ltd.
- AlphagoMed — Shenzhen Urion Technology Co., Ltd.
- AlphagoMed — Shenzhen Urion Technology Co., Ltd.
- Andesfit Health — Shenzhen Urion Technology Co., Ltd.
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
- Shenzhen Urion Technology Co., Ltd.
Sources (1)
- FDA UDI 60c653d4-0824-49c3-a0e0-f58edb69e36c 34 fields · synced Jun 1, 2026