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Wrist Type Automatic Blood Pressure Monitor
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref BP186WModel BP168W, BP166W, BP169W, BP163W, BP165W, BP188W,BP189W, BP-JC160, BP180W, BP182W, BP183W,BP185W, BP186W, BP187W
Identity
- Trade Name
- Wrist Type Automatic Blood Pressure Monitor EUDAMEDFDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Wrist type automatic blood pressure monitor EUDAMED
- Model / Reference
- BP186W EUDAMEDFDA UDIBP168W, BP166W, BP169W, BP163W, BP165W, BP188W,BP189W, BP-JC160, BP180W, BP182W, BP183W,BP185W, BP186W, BP187W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953205900566 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06953205900566 EUDAMED6953205900AE EUDAMED
- Direct Marketing DI
- 06953205900566 EUDAMED
- 510(k) Number
- K172972 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
Wrist 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 | K172972 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06953205900566 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-06953205900566 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Jiacom Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030041
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED 5a73f485-e51c-4951-bcb0-ee2ddfe201f6 61 fields · synced Oct 6, 2026
- EUDAMED c8c060d6-5669-4f93-bb79-8f59d1e36247 61 fields · synced May 17, 2026
- FDA UDI 16c6f1ee-2871-43cc-a843-fef575e07213 33 fields · synced May 30, 2026
- FDA 510(k) K172972 1 fields · synced May 18, 2026