Identity
- Trade Name
- SDUNW FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Model / Reference
- U80A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06953825909529 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
No
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
Sdunw by Shenzhen Urion Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Automatic-inflation electronic sphygmomanometer, portable, arm/wrist.
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- 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
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 ff951ae6-59a6-4d42-8d72-8c3e3e7825bc 32 fields · synced May 30, 2026