Identity
- Trade Name
- BPBIO220 EUDAMEDInBody FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- Blood Pressure Monitor EUDAMEDThe subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured. FDA UDI
- Model / Reference
- BPBIO220 EUDAMEDFDA UDIK6 EUDAMED
- Description
- The subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809209590815 EUDAMEDFDA UDI
- Basic UDI-DI
- 880920959K6Z2 EUDAMED
- Direct Marketing DI
- 08809209590815 EUDAMED
- 510(k) Number
- K200560 FDA UDI
- FDA Product Code
- DXN FDA UDIDXQ FDA UDI
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
- GMDN Term
- Aneroid manual sphygmomanometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI870.1120 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
Bpbio220 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 | 880920959K6Z2 | 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 d0569a24-d356-45f5-833c-af0a51b1c72d 61 fields · synced Jul 15, 2026
- FDA UDI e91f3776-2db1-4cd5-b155-a1ca85add076 35 fields · synced May 30, 2026