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Blood Pressure Monitor
EUDAMEDClass IIa (EU MDR)
Ref HF-B31Model HF-B11, HF-B21, HF-B31, HF-B51, HF-B61, HF-B81Ref HF-B61Ref HF-B21
Identity
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- HF-B11, HF-B21, HF-B31, HF-B51, HF-B61, HF-B81 EUDAMEDHF-B31 EUDAMEDHF-B61 EUDAMEDHF-B21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955755000062 EUDAMED06955755036108 EUDAMED06955755032100 EUDAMED
- Basic UDI-DI
- 69557550HFB001L5 EUDAMED
- Direct Marketing DI
- 06955755000062 EUDAMED06955755036108 EUDAMED06955755032100 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 (3)
- EUDAMED a670702d-f0da-492a-8fee-5b3804ee807d 61 fields · synced Oct 6, 2026
- EUDAMED 6dbf8d5d-2b9e-4fa1-a5b6-3bb6f1d58e10 61 fields · synced May 17, 2026
- EUDAMED 177192b5-38ef-456d-9bbc-68926cb02a82 61 fields · synced May 17, 2026