Identity
- Trade Name
- BPBIO250 EUDAMEDInBody FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Blood Pressure Monitor EUDAMEDThe InBody blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm. FDA UDI
- Model / Reference
- BPBIO250 EUDAMEDFDA UDIK9 EUDAMED
- Description
- The InBody blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809209590808 EUDAMEDFDA UDI
- Basic UDI-DI
- 880920959K9Z8 EUDAMED
- Direct Marketing DI
- 08809209590808 EUDAMED
- 510(k) Number
- K200442 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Bpbio250 by InBody Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 880920959K9Z8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- InBody Co., Ltd.
- EUDAMED SRN
- KR-MF-000011833
- Authorised Representative
- InBody Europe B.V. NL-AR-000011789
Sources (2)
- EUDAMED 6f32c19c-43d2-4005-b387-3ea89def8334 61 fields · synced Jul 22, 2026
- FDA UDI 8160e5d9-9fb6-448d-8edc-58267160ced7 35 fields · synced May 30, 2026