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Automatic Upper Arm Blood Pressure Monitor
EUDAMEDClass IIa (EU MDR)
Ref BU 584 connectModel BU 584 connect, HL858B1-LTRef BU 586 voiceModel HL858B1-T, BU 586 voiceRef BU 582Model BU 582, HL858B1-LRef BU 580 connectModel BU 580 connect, HL858B1-LT
Identity
- Trade Name
- Automatic Upper Arm Blood Pressure Monitor EUDAMED
- Device Name
- Automatic Upper Arm Blood Pressure Monitor EUDAMED
- Model / Reference
- BU 584 connect, HL858B1-LT EUDAMEDBU 584 connect EUDAMEDHL858B1-T, BU 586 voice EUDAMEDBU 586 voice EUDAMEDBU 582, HL858B1-L EUDAMEDBU 582 EUDAMEDBU 580 connect, HL858B1-LT EUDAMEDBU 580 connect EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872483427 EUDAMED04719872483403 EUDAMED04719872483397 EUDAMED04719872483410 EUDAMED
- Basic UDI-DI
- B-04719872483427 EUDAMEDB-04719872483403 EUDAMEDB-04719872483397 EUDAMEDB-04719872483410 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Automatic Upper Arm Blood Pressure Monitor by Health & Life Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719872483427 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Health & Life Co., Ltd
- EUDAMED SRN
- TW-MF-000027149
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED ecfc13f2-03fa-4db5-9d8e-499f665dec15 61 fields · synced Oct 5, 2026
- EUDAMED 127e497f-a8d8-4f37-91ba-e274889214b6 61 fields · synced May 18, 2026
- EUDAMED be82feab-9579-492f-8d91-60f6a03f9814 61 fields · synced Jul 10, 2026
- EUDAMED c6789baa-5c96-417d-b73f-8fd6079ed6aa 61 fields · synced Aug 5, 2026