Identity
- Trade Name
- Blood Pressure Monitor EUDAMEDDr. Max Blood Pressure Monitor EUDAMED
- Device Name
- Upper Arm Blood Pressure Monitor EUDAMED
- Model / Reference
- FDBP-A4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970389631703 EUDAMED
- Basic UDI-DI
- 697038963FDBPN8 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
Blood Pressure Monitor by Famidoc Technology 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 | 697038963FDBPN8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Famidoc Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016603
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 5cea619f-5cb3-4697-bc2c-8f6f59f74046 61 fields · synced Jun 11, 2026
- EUDAMED e2a76b39-92bc-4eff-825b-1db4f5d30764 61 fields · synced Jun 11, 2026