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Blood Pressure Monitor
EUDAMEDClass IIa (EU MDR)
Ref HF-B11Model HF-B11, HF-B21, HF-B31, HF-B51, HF-B61, HF-B81
Identity
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- HF-B11, HF-B21, HF-B31, HF-B51, HF-B61, HF-B81 EUDAMEDHF-B11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955755000031 EUDAMED
- Basic UDI-DI
- 69557550HFB001L5 EUDAMED
- Direct Marketing DI
- 06955755000031 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 Shenzhen Hopfat Medical Instrument 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 | 69557550HFB001L5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Hopfat Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000017211
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED f5b0e38a-297d-4f42-a6fe-b7eac60df68b 61 fields · synced Jun 19, 2026