Identity
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- GF-BP101 EUDAMEDGF-BP105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949395010246 EUDAMED
- Basic UDI-DI
- 69493950GF-BPSL EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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 Hangzhou Universal Electronic 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 | 69493950GF-BPSL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Universal Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000017192
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED acdb8c74-4bca-4e93-a8ac-f94da5a4aefb 61 fields · synced Jun 20, 2026