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Blood pressure monitors
EUDAMEDClass IIa (EU MDR)
Ref HS-MKB-030Model HBP-700Ref HS-MKB-037Model HBP-500
Identity
- Trade Name
- Blood pressure monitors EUDAMED
- Device Name
- EchoMax EUDAMEDBP Check W EUDAMED
- Model / Reference
- HBP-700 EUDAMEDHS-MKB-030 EUDAMEDHBP-500 EUDAMEDHS-MKB-037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800132230045 EUDAMED08800132230182 EUDAMED
- Basic UDI-DI
- 88001322BP0001YH EUDAMED88001322BP0000YF EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS 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 monitors by HuBDIC 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 | 88001322BP0001YH | Class IIa | Active |
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Manufacturer
- Manufacturer
- HuBDIC Co., Ltd
- EUDAMED SRN
- KR-MF-000014142
- Authorised Representative
- S.B. Pharma GmbH DE-AR-000005392
Sources (2)
- EUDAMED e9ace19b-2c7c-4247-8fe4-18de022eb712 61 fields · synced Jul 21, 2026
- EUDAMED f21cc6ff-3c66-42e6-9f90-a29105b866bd 61 fields · synced May 17, 2026