Identity
- Trade Name
- BP500 EUDAMED
- Model / Reference
- BP500 EUDAMEDBP500_Catalog EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08805116000423 EUDAMED
- Basic UDI-DI
- B-08805116000423 EUDAMED
- EMDN Code
- Z1203020501 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bp500 by SELVAS Healthcare, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08805116000423 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SELVAS Healthcare, Inc.
- EUDAMED SRN
- KR-MF-000019198
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 953ea902-4c1e-472c-bded-ebcfd5067049 61 fields · synced Sep 18, 2026