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Upper Arm Electronic Blood Pressure Monitor（getwell）
EUDAMEDClass 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） EUDAMED
- 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 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971522820855 EUDAMED
- Basic UDI-DI
- 697152282UABP1K2 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Upper Arm Electronic Blood Pressure Monitor（getwell） by Shenzhen Finicare Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED 091d625a-dbd2-47cd-9642-290872e04b98 61 fields · synced Jun 18, 2026