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Upper Arm Electronic Blood Pressure Monitor（getwell）
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FC-BP101Model FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112, FC-BP103, FC-BP113, FC-BP120, FC-BP130, FC-BP131
Identity
- Trade Name
- Upper Arm Electronic Blood Pressure Monitor（getwell） EUDAMEDFinicare FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Upper Arm Electronic Blood Pressure Monitor EUDAMED
- Model / Reference
- FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112, FC-BP103, FC-BP113, FC-BP120, FC-BP130, FC-BP131 EUDAMEDFC-BP101 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971522820251 EUDAMEDFDA UDI
- Basic UDI-DI
- 697152282UABP1K2 EUDAMED
- 510(k) Number
- K220113 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
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
Upper Arm Electronic Blood Pressure Monitor（getwell） by Shenzhen Finicare 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 | 697152282UABP1K2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Finicare Co., Ltd.
- EUDAMED SRN
- CN-MF-000024364
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 33afce24-f7fa-4363-b3f7-dcf17c310668 61 fields · synced Jun 18, 2026
- FDA UDI b5b47aca-dcef-4af2-8b39-f44d6b7ef87b 33 fields · synced May 30, 2026