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Digital Blood Pressure Monitor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BP101YModel BP101B, BP101E, BP101G, BP101H, BP101K, BP101N, BP101W, BP101Y, BP101U, BPx2, BP101D
Identity
- Trade Name
- Upper Arm Blood Pressure Monitor FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Digital Blood Pressure Monitor EUDAMED
- Model / Reference
- BP101B, BP101E, BP101G, BP101H, BP101K, BP101N, BP101W, BP101Y, BP101U, BPx2, BP101D EUDAMEDBP101Y EUDAMEDBLDP-ARM-02-WL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944249300924 EUDAMEDFDA UDI
- Basic UDI-DI
- 069442493101C8 EUDAMED
- 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
No
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
Digital Blood Pressure Monitor by Shenzhen Kingyield Technology Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 069442493101C8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Kingyield Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000030898
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 4546d263-7b9f-4daf-afb1-96ad554498ec 61 fields · synced Jun 20, 2026
- FDA UDI 01193f73-3375-4f4d-b786-d916023b1676 32 fields · synced May 22, 2026