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Blood Pressure Monitor
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref P3Model KOROT P3 Accurate
Identity
- Trade Name
- KOROT FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Blood Pressure Monitor EUDAMEDBlood pressure monitor designed to measure blood pressure (diastolic and systolic) and pulse rate FDA UDI
- Model / Reference
- KOROT P3 Accurate EUDAMEDFDA UDIP3 EUDAMED
- Description
- Blood pressure monitor designed to measure blood pressure (diastolic and systolic) and pulse rate FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809930290022 EUDAMEDFDA UDI
- Basic UDI-DI
- 880993029P32L EUDAMED
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER 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
- Netherlands 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Blood Pressure Monitor by KOROT Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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 | K250091 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 880993029P32L | Class IIa | Active |
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Manufacturer
- Manufacturer
- KOROT Co, .Ltd.
- EUDAMED SRN
- KR-MF-000037245
- Authorised Representative
- InBody Europe B.V. NL-AR-000011789
Sources (3)
- EUDAMED 21b3192d-c9e5-4b6c-8bb0-ba5166fd5cb6 61 fields · synced Jun 19, 2026
- FDA UDI 96c2d556-de0b-4a95-b2ab-b2756c766fda 35 fields · synced May 27, 2026
- FDA 510(k) K250091 1 fields · synced May 18, 2026