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MED-55 Automatic blood pressure monitor

by B.Well Swiss AG 3 variants

Ref 1101665Model MED-53, MED-55, MED-50, MED-51, MED-56, MED-58, MED-80, MED-81, MED-88, MED-55 G.IV, TH-75

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number764015639MDA0203_8LP Basic UDI-DI 07640156399301UDI-DIDate8 Apr 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Blood Pressure Monitor
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, 1101665
Primary DI / UDI-DI
07640156399301
Basic UDI-DI
764015639MDA0203_8LP
Direct Marketing DI
07640156399301
EMDN Code
Z1203020302 Non–invasive blood pressure monitoring instruments
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000012588
Authorised representative
Blue Broccoli GmbH LI-AR-000000233

Other devices from B.Well Swiss AG

See all devices from B.Well Swiss AG →

Properties

  • Measuring Function

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No