Identity
- Trade Name
- BP 868F EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- BP 868F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809282071218 EUDAMED
- Basic UDI-DI
- 92820AMP-BP-Monitor8C EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS 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
Bp 868f by Ampall 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 | 92820AMP-BP-Monitor8C | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ampall Co., Ltd
- EUDAMED SRN
- KR-MF-000010967
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED d03a603b-fd2c-46ee-8f5b-417b4e852d44 61 fields · synced Jul 9, 2026