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MED-58 Automatic blood pressure monitor
EUDAMEDClass IIa (EU MDR)
Ref 1101659Model MED-53, MED-55, MED-50, MED-51, MED-56, MED-58, MED-80, MED-81, MED-88, MED-55 G.IV, TH-75Ref 1101617
Identity
- Trade Name
- MED-58 Automatic blood pressure monitor EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMED
- Model / Reference
- MED-53, MED-55, MED-50, MED-51, MED-56, MED-58, MED-80, MED-81, MED-88, MED-55 G.IV, TH-75 EUDAMED1101659 EUDAMED1101617 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640156399288 EUDAMED07640156398786 EUDAMED
- Basic UDI-DI
- 764015639MDA0203_8LP EUDAMED
- Direct Marketing DI
- 07640156399288 EUDAMED07640156398786 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania EUDAMEDCroatia 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-58 Automatic 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_8LP | 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 (2)
- EUDAMED d47f9bd2-52d4-4866-aac7-e0f54d9388ea 61 fields · synced Oct 6, 2026
- EUDAMED 7a62dfe2-c7db-4984-9c14-5eb11df47752 61 fields · synced May 18, 2026