Arm Type Automatic Blood Pressure Monitor
by Shenzhen Jiacom Technology Co., Ltd. 28 variants
Ref BP351AModel BP310A,BP311A,BP313A,BP315A,BP316A,BP317A,BP318A,BP319A,BP320A,BP351A,BP353A,BP358A,BP359A,BP360A,BP362A,BP366A,BP367A,BP368A,BP369A,BP370A,BP380A,BP382A,BP385A,BP386A,BP387A,BP388A,BP389A,BP390A,BP391A,BP-JC319,BP-JC312
Active
CE MDD
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-06953205900030 | Date4 Mar 2024 | StatusActive |
| United States | GUDID listing GUDID | Number06953205900030 | Date3 Jul 2018 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
- Model / Reference
- BP351A, BP310A, BP311A, BP313A, BP315A, BP316A, BP317A, BP318A, BP319A, BP320A, BP353A, BP358A, BP359A, BP360A, BP362A, BP366A, BP367A, BP368A, BP369A, BP370A, BP380A, BP382A, BP385A, BP386A, BP387A, BP388A, BP389A, BP390A, BP391A, BP-JC319, BP-JC312
- Primary DI / UDI-DI
- 06953205900030, 06953205995098
- Basic UDI-DI
- B-06953205900030, 6953205901AG
- Direct Marketing DI
- 06953205995098
- 510(k) Number
- FDA Product Code
- DXN
- EMDN Code
- Z1203020302 Non–invasive blood pressure monitoring instruments
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 870.1130
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000030041
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Jiacom Technology Co., Ltd
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No