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Upper Arm Electronic Blood Pressure Monitor
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref FC-BP106Model FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112, FC-BP103, FC-BP113, FC-BP120, FC-BP130, FC-BP131Ref FC-BP120Ref FC-BP112Ref FC-BP110Ref FC-BP103
Identity
- Trade Name
- Upper Arm Electronic Blood Pressure Monitor EUDAMEDDr. Max Upper Arm Electronic Blood Pressure Monitor 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-BP106 EUDAMEDFC-BP120 EUDAMEDFC-BP110 EUDAMEDFDA UDIFC-BP103 EUDAMEDFDA UDIFC-BP112 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971522820503 EUDAMED08595566424961 EUDAMED06971522820275 EUDAMEDFDA UDI06971522820312 EUDAMEDFDA UDI06971522820299 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 EUDAMEDCzechia 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 by Shenzhen Finicare Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242721 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697152282UABP1K2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Finicare Co., Ltd.
- EUDAMED SRN
- CN-MF-000024364
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (9)
- EUDAMED fa803a34-8608-42cf-965b-456c2e2452c4 61 fields · synced Oct 6, 2026
- EUDAMED baad87db-3e21-4983-b21f-869b87c99697 61 fields · synced May 16, 2026
- FDA UDI 226d4e57-6077-415b-9423-a3562d865092 33 fields · synced May 30, 2026
- FDA UDI 3cae418e-2dd1-4629-8298-c1d8828b4611 33 fields · synced May 30, 2026
- FDA UDI df373ea2-0725-4cd8-bed9-caac8cdda0bd 33 fields · synced May 30, 2026
- EUDAMED b2c61582-f020-475e-9774-28806d940a3d 61 fields · synced Jul 18, 2026
- EUDAMED 6ab6c690-397b-4848-8f75-c6d21a4e886e 61 fields · synced Jul 31, 2026
- EUDAMED 86f460bf-64b4-48a0-ba22-a013194949c6 61 fields · synced Aug 2, 2026
- FDA 510(k) K242721 1 fields · synced May 18, 2026