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Wrist Type Automatic Blood Pressure Monitor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BP168WModel 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
- BP168W, BP166W, BP169W, BP163W, BP165W, BP188W,BP189W, BP-JC160, BP180W, BP182W, BP183W,BP185W, BP186W, BP187W EUDAMEDBP168W EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06953205900535 EUDAMEDFDA UDI
- Basic UDI-DI
- 6953205900AE EUDAMEDB-06953205900535 EUDAMED
- Direct Marketing DI
- 06953205900535 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 — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6953205900AE | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6953205900AE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (3)
- EUDAMED 93aade9c-e361-4e9b-b692-aecc70cf73fa 61 fields · synced Oct 5, 2026
- EUDAMED 9bb20da4-f6d3-46b5-aab6-93b24048806d 61 fields · synced May 18, 2026
- FDA UDI 9a4376cc-b9fa-404e-add4-640185b9f0e8 33 fields · synced May 30, 2026