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Bp-Hd-L-01
EUDAMEDClass I (EU MDR)
Ref K8Model Cuff for Blood Pressure Monitor [BPBIO/BP series]
Identity
- Trade Name
- BP-HD-L-01 EUDAMED
- Model / Reference
- Cuff for Blood Pressure Monitor [BPBIO/BP series] EUDAMEDK8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809209591485 EUDAMED
- Basic UDI-DI
- 880920959K8Z6 EUDAMED
- Direct Marketing DI
- 08809209591485 EUDAMED
- EMDN Code
- Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bp-Hd-L-01 by InBody Co., Ltd. — Class I — 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 | 880920959K8Z6 | Class I | 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 (1)
- EUDAMED 51febda2-3283-4bfd-b38e-23cf9c55ba3e 61 fields · synced Jul 9, 2026