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MED-57 Wrist blood pressure monitor
EUDAMEDClass IIa (EU MDR)
Ref 1101241Model MED-57, MED-59, MED-89
Identity
- Trade Name
- MED-57 Wrist blood pressure monitor EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- MED-57, MED-59, MED-89 EUDAMED1101241 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640156395044 EUDAMED
- Basic UDI-DI
- 764015639MDA0203_9LR EUDAMED
- Direct Marketing DI
- 07640156395044 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
MED-57 Wrist blood pressure monitor by B.Well Swiss AG — 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 | 764015639MDA0203_9LR | Class IIa | Active |
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Manufacturer
- Manufacturer
- B.Well Swiss AG
- EUDAMED SRN
- CH-MF-000012588
- Authorised Representative
- Blue Broccoli GmbH LI-AR-000000233
Sources (1)
- EUDAMED c6e27980-b4a2-40f3-803c-694d5feba11e 61 fields · synced Oct 6, 2026