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Braun ExactFit 1, BUA4000EU

by KAZ Europe Sàrl EUDAMED

Active European Union

Ref BUA4000EUModel BUA4000 / BUA4050

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000305898 Date1 Jul 2026IssuedStatusActive expires 29 Jul 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000305898 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    1 Jul 2026
    Expires
    29 Jul 2029
    Reason
    Add device or group

Specification

EUDAMED

Device Name
Braun ExactFit 1E / Braun ExactFit 2
Model / Reference
BUA4000 / BUA4050, BUA4000EU
Primary DI / UDI-DI
07630759301900, 07630759300095
Basic UDI-DI
76307593BP4000CJ
Direct Marketing DI
07630759301900
07630759300095
EMDN Code
Z1203020302 Non–invasive blood pressure monitoring instruments
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CH-MF-000029980
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

Show 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