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Arm type automatic blood pressure monitor
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref BP313AModel 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 Ref BP351A
Identity
- Trade Name
- Arm type automatic blood pressure monitor EUDAMEDFDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Arm type automatic blood pressure monitor EUDAMED
- Model / Reference
- 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 EUDAMEDBP313A EUDAMEDBP351A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06953205995081 EUDAMED06953205900030 EUDAMEDFDA UDI
- Basic UDI-DI
- 6953205901AG EUDAMEDB-06953205900030 EUDAMED
- Direct Marketing DI
- 06953205995081 EUDAMED
- 510(k) Number
- K172896 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Arm type automatic blood pressure monitor by Shenzhen Jiacom Technology Co., Ltd — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172896 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 6953205901AG | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6953205901AG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Jiacom Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030041
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (4)
- EUDAMED 13e4a843-cabc-498b-b715-5eda62c074ba 61 fields · synced Oct 6, 2026
- EUDAMED 58be02db-40ed-4c21-a021-1bebd2fce589 61 fields · synced May 17, 2026
- FDA UDI 541b9114-30c1-4d24-9d93-b1e5ebd90b3a 33 fields · synced May 30, 2026
- FDA 510(k) K172896 1 fields · synced May 18, 2026