Identity
- Trade Name
- BPBIO320n EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- BPBIO320 EUDAMEDE4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809209591140 EUDAMED08809209591157 EUDAMED
- Basic UDI-DI
- 880920959F2YB EUDAMED
- Direct Marketing DI
- 08809209591140 EUDAMED08809209591157 EUDAMED
- EMDN Code
- Z12062699 DYNAMOMETRIC SYSTEMS FOR MOVEMENT ANALYSIS – OTHER EUDAMEDZ1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
BPBIO320n by InBody 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 | 880920959F2YB | Class IIa | Active |
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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 b26f46ed-e116-4ae6-a41b-ed9645716df3 61 fields · synced Aug 1, 2026
- EUDAMED 89bc21ed-0f57-4bbe-88aa-5819b1387a28 61 fields · synced May 19, 2026