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B Well
FDA UDIClass II (US FDA UDI)
by Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
Identity
- Trade Name
- B WELL FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
- Device Name
- Blood pressure monitor FDA UDI
- Model / Reference
- ePA-09B4 FDA UDI
- Description
- Blood pressure monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947468556455 FDA UDI
- 510(k) Number
- K134029 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, non-portable 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
Yes
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, non-portable
B Well by Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automatic-inflation electronic sphygmomanometer, non-portable.
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- microlife — MICROLIFE USA, INC. · Class II
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- Tango M2 — SUNTECH MEDICAL, INC. · Class II
- AdviewII™ — American Diagnostic Corporation · Class II
Cleared under the same submission
K134029 also covers:
- J.Stanar — Guangzhou Daxin health technology Co., Ltd
- BELTER — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
- Contact Health — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
- Koogeek — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
- PORTAL724 — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
- Smart Blood Pressure Monitor — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
- biotricity — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
- biotricity — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
- eocene — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
- eufy — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
- koogeek — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
- koogeek — Shenzhen Belter Health Measurement and Analysis 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
Sources (1)
- FDA UDI cab40420-9a2c-404f-af7c-9e0682818142 34 fields · synced May 30, 2026