Identity
- Trade Name
- HOMIEE FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
- Model / Reference
- BP1003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06948158404469 FDA UDI
- 510(k) Number
- K181104 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
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
Yes
FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, non-portable
Homiee by Shenzhen Combei 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.
- Blood Pressure Monitor CH-4532 — CITIZEN SYSTEMS JAPAN CO., LTD. · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- Spotskan — Skanray Technologies · Class II
- PORTAL724 — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. · Class II
- ri-champion® N, Pull through strap velcro cuff adult obese size, latex free — Rudolf Riester GmbH & Co. KG · Class II
- microlife — MICROLIFE USA, INC. · Class II
- A&D Medical — A & D Co., Ltd. · Class II
- Tango M2 — SUNTECH MEDICAL, INC. · Class II
Cleared under the same submission
K181104 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Combei Technology Co., Ltd
Sources (1)
- FDA UDI 93056652-1dcf-4251-9abe-62fb6c23c41e 33 fields · synced May 30, 2026